Sex: U
Vaccine: PNC15
Symptoms: Syringe issue
Clinical narrative: No AE reported; pre-filled syringes broke when the needle was being attached; Healthcare provider reports 2 pre-filled syringes broke when the needle was being attached. Caller states only 1 pre-filled syringe is available for retrieval as the other has been discarded and not available for retrieval. Caller states she can send pictures to email for the one available syringe that is available for retrieval. Caller confirmed doses involved in product quality complaint were not administered to patients. No AE reported. No additional PQC reported. Associated case 02254308.   LOT: W021512 EXP: 08-OCT-2023 NDC: 0006-4329-01 NDC: NDC 0006-4329-03 (10 count)  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? No                 o If yes, describe the size, shape and depth of the crack: NA                 o Provide the exact location of the crack on the syringe: NA         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.) PRE-FILLED SYRINGES BROKE IN HALF AT THE NECK WHERE THE HUB IS ATTACHED                 o Provide the exact location of the breakage on the syringe?  PRE-FILLED SYRINGES BROKE IN HALF AT THE NECK WHERE THE HUB IS ATTACHED          o Does the syringe have a broken component? YES- BROKEN LUER LOCK DETACHED                  o If yes, describe in detail how it is broken. PRE-FILLED SYRINGE BROKE OFF WHEN THE NEEDLE WAS BEING ATTACHED                 o Provide the exact location of the breakage on the syringe? WHERE THE NECK AND HUB MEET                 o Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip?  YES, BROKEN OFF OF THE NECK          o Was there difficulty trying to attach the syringe needle to the syringe? UNSPECIFIED                    o If yes, describe: UNKNOWN BY REPORTER                    o If yes, was it supplied by MERCK: UNKNOWN BY REPORTER                    o If not supplied by MERCK, what type and brand, needle size and gauge was used?' SAFETY NEEDLE, 24 GAUGE, 1 INCH  o Under what situation was this defect noticed: (select one)         o While the syringe was still in the tray? NO                 o If yes, is there product (liquid or dried residue) in the tray? NA                 o Is there any broken glass or other separated component in the tray? NA          o After removing the syringe from the tray? NA          o While trying to attach the needle to the syringe? YES           o While giving the injection? NA           o Immediately after giving the injection? NA  o Was the syringe tip cap attached properly prior to use?NA          o If no, describe issue: NA  o Was the syringe tray intact and undamaged on receipt? UNSPECIFIED         o If no, describe damage. NA  o If the product came with a cellophane cover, was the cellophane covering the syringe tray intact and completely sealed? UNSPECIFIED         o If no, describe damage: NA  o Was the syringe carton damaged prior to use?  (i.e. crushed, ripped, unglued) UNSPECIFIED           o If yes, describe: NA  o Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? NO  o If complaint sample is not/cannot be returned, please provide reason: YES   Retrieval Information:  o Obtain product (and 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 Insertion Difficulty:  Insertion Difficulty Details:  Doubt About Presence:  Doubt Details:  Migration:  Migration Details:   Removal Problem:   Removal Problem Details:  26-SEP-2022 13:30: Outbound call placed to customer to confirm if the broken pre-filled syringe was part of a carton of 10 pre-filled syringes or part of a carton of 1 pre-filled syringe. Agent left a voicemail for customer to call back in reference to this case.   NEXT AGENT: If customer calls back please confirm if the syringes were part of a package of 10 prefilled syringes or a package of 1 pre-filled syringes. Please reach out the case owner when this information has been obtained.  26-SEP-2022 13:30: Inbound call received from customer in interaction. She states that the PQC product was from a carton of 10 pre-filled syringes. No other information provided; no other PQC/no AE.  26-SEP-2022 13:30 PM: Attachment added.  26-SEP-2022: First Person - Requested Admin add Product ID which corresponds with reported lot W021512. In meantime, pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) 0.5ml 1 Dose Syringe was used.  26-SEP-2022: First Person - Requested confirm that both syringes were from reported lot W021512.  26-SEP-2022: First Person - Product ID updated which has been updated.  26-SEP-2022: Second person reviewed  26-SEP-2022 16:30: Attachment added  26-SEP-2022 16:30: Email received in the Contact Center Mailbox on 26-SEP-2022 at 23:36 with information for this case which includes pictures.  26-SEP-2022: first person- PHOTOS received and attached  27-SEP-2022 12:30: Case opened to change product lookup from pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) to pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) INJ 0.5 mL 1DS X 10 SYRINGES 00006432903  27-SEP-2022: first person - Based on review of the photos received it appears the tip of the syringe has broken off but there is no damage to the Luer Lock area the complaint category details was updated to Broken.  27-SEP-2022:  Second person reviewed by other person