1 syringe with detached finger flange ring may have been administered; 1 syringe with detached finger flange ring may have been administered; No adverse event; Complaint Description Detail Employee calling on behalf of health care professional (HCP), who is not on the line, to initiate product quality complaint for pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE). Employee reports that 2prefilled syringes (PFS) from 1 carton are broken: 1 PFS loose finger flange near plunger and 1 PFS broken near luer lock. No further information available at this time. No adverse events (AEs), no additional PQCs reported at this time. Employee will send photos via email and best time to contact HCP on 12-APR-2023. QUESTION SECTION: Medium Risk: Broken Syringe Barrel High Risk: Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange.  Notes: o A cracked syringe has a line or chip in the glass, but the syringe is essentially intact in one piece. A syringe is considered broken when the syringe is in 2 or more pieces. o A syringe is also considered "cracked" if it appears to be intact with evidence of a chip or crack OR appears to be intact initially but then breaks into 2 or more pieces during use (such as while attaching a needle or injecting diluent).  o Please provide a detailed description of the defect using the questions below: o Is there a crack? YES/NO/NA/UNSPECIFIED o If yes, describe the size, shape & depth of the crack: o Provide the exact location of the crack on the syringe: o Is the syringe broken into 2 or more pieces? YES/NO/NA/UNSPECIFIED o If yes, describe in detail how it is broken: (e.g. shattered, broken in half etc.) o Provide the exact location of the breakage on the syringe? o Does the syringe have a broken component? YES/NO/NA/UNSPECIFIED (e.g. broken syringe tip; loose or detached luer lock, or broken finger flange) o If yes, describe in detail how it is broken. o Provide the exact location of the breakage on the syringe? o Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? YES/NO/NA/UNSPECIFIED (if yes describe) o Was anyone injured as a result of the breakage? YES/NO/NA/UNSPECIFIED o If yes, provide brief description of injury o Note: Report an AE if yes as outlined in Instruction section o Was there difficulty trying to attach the syringe needle to the syringe? YES/NO/NA/UNSPECIFIED o If yes, describe o If yes, was it supplied by MERCK: YES/NO/NA/UNSPECIFIED o If not supplied by MERCK, what type & brand, needle size & gauge was used?' o Under what situation was this defect noticed: (select one) o While the syringe was still in the tray? YES/NO/NA/UNSPECIFIED o If yes, is there product (liquid or dried residue) in the tray? YES/NO/NA/UNSPECIFIED o Is there any broken glass or other separated component in the tray? (if yes specify) o After removing the syringe from the tray? YES/NO/NA/UNSPECIFIED o While trying to attach the needle to the syringe? YES/NO/NA/UNSPECIFIED o While giving the injection? YES/NO/NA/UNSPECIFIED o Immediately after giving the injection? YES/NO/NA/UNSPECIFIED o Was the syringe tip cap attached properly prior to use? YES/NO/NA/UNSPECIFIED o If no, describe issue: o Was the syringe tray intact and undamaged on receipt? YES/NO/NA/UNSPECIFIED o If no, describe damage o If the product came with a cellophane cover, was the cellophane covering the syringe tray intact and completely sealed? *See below. YES/NO/NA/UNSPECIFIED o If no, describe damage o Was the syringe carton damaged prior to use? (i.e. crushed, ripped, unglued) YES/NO/NA/UNSPECIFIED o If yes, describe o Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? YES/NO/NA/UNSPECIFIED o If complaint sample is not/cannot be returned, please provide reason: *If photos are available, ask the customer to send them Retrieval Information: o Obtain product (& tray if possible) o Expedite return for cracked syringes. If there is a doubt whether it is cracked or broken, please expedite. NOTE: Vaccine Prefilled Syringes may be returned even if biohazardous. Sample Tracking Number: User's Experience: Repeat User 11-APR-2023 18:30 PM :Email received to the Contact Center inbox on 11-APR-2023 at 1647 with an image attachment that cannot be viewed that is associated with this case. Sending to case owner to follow up and request the attachment be sent in a different format. See attached. No AE/PQC. No additional information. 11-APR-2023 18:30 PM :Attachment added. 12-APR-2023: The complained product photograph has been converted from HEIC to JPEG format and attached in the reference tab. The PQC categories are selected based on the complaint's narrative. Since the reporter stated that 'Employee reports that 2 PFS from 1 carton are broken: 1 PFS loose finger flange near plunger and 1 PFS broken near luer lock', the PQC categories 'Broken syringe' and 'Syringe Hub Defect > broken' have been selected respectively. The PQC category 'Broken syringe' will be investigated by the packaging site And the manufacturing site has been selected to investigate the 'Syringe Hub Defect > Broken'. Based on the verification of the complained product photographs, lot #W027250 for the defective product is visible. Since the employee reports that 2 PFS from 1 carton are broken, the record has been updated with lot # W027250. Has been requested to confirm if this is the correct lot# for the reported case. Furthermore, as per the narrative of the complaint, two PFS are broken. One PFS loose finger flange near the plunger and another PFS was broken near the luer lock. However, in the photograph, there is only one syringe with a broken finger flange. Hence, has been requested to provide a picture of another syringe that was broken near the luer lock. In addition to the above, as per the complained product photographs, additional pieces of broken finger flange are seen. Hence, agency has been requested to confirm if any other syringe had a broken finger flange. Agency has been notified through email and the same communication is attached in the reference tab. Post confirmation received from the agency, the \ required changes in the record will be initiated. 12-APR-2023: Second person review completed. 12-APR-2023 11:30 AM :Outbound call to HCP to collect details and photos for PQC. VM left on recorded message. 12-APR-2023 14:30 PM :Attachment added. 12-APR-2023 14:30 PM :Email received in the PQC Mailbox on 12-APR-2023 at 1:49AM with the following message from Quality: "Based on the verification of the complained product photographs (converted the pictures from HEICs to JPEGs), lot #W027250 for the defective product is visible (Refer to the encircled section in RED). Since the employee reports that 2 PFS from 1 carton are broken, the record has been updated with lot # W027250. Please confirm if this is the correct lot# for the reported case. Furthermore, as per the narrative of the complaint, two PFS are broken. One PFS loose finger flange near the plunger and another PFS was broken near the luer lock. However, in the photograph, there is only one syringe with a broken finger flange. Hence, please provide a picture of another syringe that was broken near the luer lock. In addition to the above, as per the complained product photographs, additional pieces of broken finger flange (Refer to the encircled section in YELLOW) are seen. Please confirm if any other syringe had a broken finger flange." See attached. Forwarded to case owner for follow-up. 12-APR-2023 16:30 PM :2nd outbound call to HCP who is currently with patient. HCP will call back at end of day. Case number and callback number provided. Next agent: if case owner is unavailable when HCP calls back, please have HCP answer PQC questions in Notes, request photo of 2nd broken PFS as mentioned, and obtain details for CR case. Thank you! 12-APR-2023 18:30 PM :QUESTION SECTION: High Risk: 1 Broken Finger Flange and 1 Cracked Finger Flange Notes: o A cracked syringe has a line or chip in the glass, but the syringe is essentially intact in one piece. A syringe is considered broken when the syringe is in 2 or more pieces. o A syringe is also considered "cracked" if it appears to be intact with evidence of a chip or crack OR appears to be intact initially but then breaks into 2 or more pieces during use (such as while attaching a needle or injecting diluent). o Please provide a detailed description of the defect using the questions below: o Is there a crack? NO o If yes, describe the size, shape & depth of the crack: N/A o Provide the exact location of the crack on the syringe: N/A o Is the syringe broken into 2 or more pieces? YES o If yes, describe in detail how it is broken: (e.g. shattered, broken in half etc.) 1 SYRINGE HAS FINGER FLANGE BROKEN OFF COMPLETELY. o Provide the exact location of the breakage on the syringe? SEE ABOVE o Does the syringe have a broken component? YES. 1 BROKEN FINGER FLANGE, STILL ATTACHED TO BARREL o If yes, describe in detail how it is broken. SEE PHOTO o Provide the exact location of the breakage on the syringe? FINGER FLANGE o Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? NO o Was anyone injured as a result of the breakage? NO o If yes, provide brief description of injury N/A o Note: Report an AE if yes as outlined in Instruction section o Was there difficulty trying to attach the syringe needle to the syringe? N/A o If yes, describe N/A o If yes, was it supplied by MERCK: N/A o If not supplied by MERCK, what type & brand, needle size & gauge was used?' N/A o Under what situation was this defect noticed: (select one) o While the syringe was still in the tray? YES o If yes, is there product (liquid or dried residue) in the tray? YES Is there any broken glass or other separated component in the tray? YES, SHARDS OF GLASS & BROKEN FLANGE RING DETACHED FROM BARREL o After removing the syringe from the tray? N/A o While trying to attach the needle to the syringe? N/A o While giving the injection? N/A o Immediately after giving the injection? N/A o Was the syringe tip cap attached properly prior to use? N/A o If no, describe issue: o Was the syringe tray intact and undamaged on receipt? YES o If no, describe damage. N/A o If the product came with a cellophane cover, was the cellophane covering the syringe tray intact and completely sealed? *See below. UNKNOWN. ANOTHER HCP OPENED IT. o If no, describe damage N/A o Was the syringe carton damaged prior to use? (i.e. crushed, ripped, unglued) NO o If yes, describe N/A o Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? 1 SYRINGE WITH DETACHED FINGER FLANGE RING MAY HAVE BEEN ADMINISTERED. BROKEN RING WAS FOUND IN TRAY W/NO SYRINGE. If complaint sample is not/cannot be returned, please provide reason: 1 SYRINGE IS AVAILBLE FOR RETURN. *If photos are available, ask the customer to send them SENT. SEE ATTACHMENTS. Retrieval Information: o Obtain product (& tray if possible) o Expedite return for cracked syringes. If there is a doubt whether it is cracked or broken, please expedite. NOTE: Vaccine Prefilled Syringes may be returned even if biohazardous. 12-APR-2023 18:30 PM :Case reopened to updated details of PQC: Inbound call from HCP transferred. Details of case provided. HCP clarified information as shown in photo: 1 syringe has broken finger flange still attached and 1 syringe is broken into 2 pieces with finger flange completely detached with ring fragments still in tray without the broken syringe. No other syringe was noted to have broken or cracked components. No syringe had broken luer lock. Precautionary AE filed for missing broken syringe and HCP could not confirm if administered. 12-Apr-2023 18:30 PM :Inbound call received from the customer. Caller was not certain if any patient received pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) from the broken syringe. Precautionary AE was filed by the case owner and caller was transferred to the case owner. No additional AE/PQC reported. No further information was provided. 12-APR-2023 18:30 PM :Attachment added. 12-Apr-2023 18:30 PM :Attachment added. 13-Apr-2023: As per the updated information through the interface (on 12-APR-2023 18:30 PM), it has been confirmed that both the syringes are broken at the finger flange. One syringe has a broken finger flange still attached and another syringe is broken into two pieces with the finger flange completely detached with ring fragments. No syringe had a broken luer lock. Furthermore, Precautionary AE filed for a missing broken syringe and HCP could not confirm if administered. Accordingly, the Adverse Event Indicated' field has been marked as Yes'. Based on the updated information, following changes have been made to the record. 1) The existing PQC category Syringe Hub Defect > Broken' has been removed from the record. 2) The number of occurrences for the PQC category Broken Syringe' has been changed from 1' to 2'. 3) Since AE is marked as Yes', the patient code has been updated as Refer to record'. 4) Device code field is also updated accordingly. 5) The site has been removed from Lead. 6) Complaint description summary has been updated accordingly. Both manufacturing, packaging site and the team has been informed about the same. 13-APR-2023 09:30 AM :Waiting retrieval site from Quality -- see attachment 13-APR-2023 09:30 AM :Attachment added. 13-APR-2023: Second person review completed 14-APR-2023: Based on further review of the updated information (received on 12-Apr-2023 18:30 PM through the interface) and as suggested by the team, it seems that the second syringe (with the flange completely detached with ring fragments still in the tray without the syringe) might have broken during/after injection. Conservatively, even though the HCP could not confirm if the second syringe was administered to the patient or not, an additional PQC category Broken Syringe > Broken During or After injection' has been selected with 1' number of occurrences. Accordingly, the number of occurrences for the first syringe has been changed from 2' to 1'. The priority of the record has been changed from Medium Risk' to High Risk'. Due to the change in complaint category, the fields have been updated and the case became Reportable'. The device code for newly added category has been updated and e-signature has been performed. Lead team has been informed about the changes. 14-APR-2023: Second Person Review completed. 14-APR-2023 15:30 PM :Attachment added. 14-APR-2023 15:30 PM :Retrieval site. 14-APR-2023 15:30 PM Labels created. Shipped on 4/14/2023 14-APR-2023 15:31 PM :Labels created. Shipped on 4/14/2023  Complaint Description Summary One syringe has a broken finger flange still attached and another syringe is broken into two pieces with the finger flange completely detached with ring fragments (the second syringe might have broken during/after injection)