Sex: U
Vaccine: HPV9
Symptoms: Syringe issue
Clinical narrative: No additional AEs; the glass syringe surrounding the flange broke into two pieces while being administered to a patient.; the other piece fell into the HCP's hand; cellophane seal not present/ incomplete or missing packaging; Complaint Description Detail.  22-FEB-2023: Note: As complainant reported tat this is the third time this has happened with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). An additional PQC has been created with PR#381785 to report this event. Lot number was captured as unknown in PR# 381785 as no further information was available with the reporter, regarding this event. This PQC will capture the event with known lot # W021492 and PR#381785 will capture the event with unknown lots.  Agency calling in to report a PQC on behalf of a HCP with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringes. Agency reports that she received an email from the HCP on 17-FEB-2023 regarding this issue. The company awareness date reflects the date the employee received the email. However, the employee was on PTO and called to report the PQC on 20-FEB-2023 during Merck business hours. Agency reports that the HCP stated in the email the glass syringe broke when it was handled. Agency reports that the edges are sharp. Agency reports that the HCP included a photo of the product in the email sent. Agency reports that this is the third time in the last month that this has happened with their hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) syringes. No further information was known or provided by the agency to further clarify any details or a timeline of events. No additional PQC information.   Outbound call to HCP to confirm details of the broken hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) syringe. HCP reports that the glass syringe surrounding the flange broke into two pieces while being administered to a patient. HCP reports the vaccine had been given and as the needle was being removed from the patient's arm, the glass syringe surrounding the finger flange broke into two pieces. HCP reports one piece fell into the syringe tray and the other piece fell into the HCP's hand. HCP reports the broken pieces are jagged and sharp. HCP reports the product cannot be returned to the company as the product was placed in the sharps container. HCP reports the patient was not affected by this event and no medical attention or treatment was given. HCP reports that they have had issues with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) syringes and this is the third time in the last month that this has happened; no additional information was provided regarding previous events therefore AE/PQC filed out of precaution, see case 02339639. No further information was provided to further clarify any details or a timeline of events. Consent to contact the HCP was provided. No additional AEs/no additional PQCs.  QUESTION SECTION: Medium Risk: Broken Syringe Barrel High Risk: Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange.   Notes for agency:  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. The bottom of the glass part (neck) around the flange broke off. 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).  Please provide a detailed description of the defect using the questions below: Is there a crack? NO. If yes, describe the size, shape & depth of the crack: N/A Provide the exact location of the crack on the syringe: N/A  Is the syringe broken into 2 or more pieces? YES.  If yes, describe in detail how it is broken: (e.g. shattered, broken in half etc.): the bottom of the syringe (finger flange) broke into two pieces.  Provide the exact location of the breakage on the syringe? The glass surrounding the finger flange and syringe plunder rod.   Does the syringe have a broken component? NO. (e.g. broken syringe tip; loose or detached luer lock, or broken finger flange) If yes, describe in detail how it is broken. N/A Provide the exact location of the breakage on the syringe? N/A Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? N/A  Was there difficulty trying to attach the syringe needle to the syringe? NO.  If yes, describe N/A If yes, was it supplied by MERCK N/A If not supplied by MERCK, what type & brand, needle size & gauge was used?' N/A  Under what situation was this defect noticed:  While the syringe was still in the tray? YES/NO/NA/UNSPECIFIED If yes, is there product (liquid or dried residue) in the tray? YES/NO/NA/UNSPECIFIED Is there any broken glass or other separated component in the tray? (if yes specify)  After removing the syringe from the tray? N/A  While trying to attach the needle to the syringe? N/A  While giving the injection? Yes. The defect was noticed while administering the vaccine. When the needle was removed from the patient's arm.   Immediately after giving the injection? N/A  Was the syringe tip cap attached properly prior to use? YES.  If no, describe issue: N/A  Was the syringe tray intact and undamaged on receipt? YES.  If no, describe damage. N/A  If the product came with a cellophane cover, was the cellophane covering the syringe tray intact and completely sealed? No, the product did not come with a cellophane cover. If no, describe damage N/A  Was the syringe carton damaged prior to use?  (i.e. crushed, ripped, unglued) NO. If yes, describe N/A  Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? Yes the product was administered to a patient. When the glass syringe broke, one part fell into the syringe tray and the other part fell into the hcp's hand.   If complaint sample is not/cannot be returned, please provide reason: no. The product cannot be returned as it was placed in the sharps container.   If photos are available, ask the customer to send them  Retrieval Information:  Obtain product (& tray if possible) 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: 21-FEB-2023 18:30 PM: Attachment added. 21-FE-2023 18:30 PM: Email received in the Mailbox on 21-FEB-2023 at 2:31pm with a forwarded email for this case including pictured. See attached. 21-FEB-2023 18:30 PM: Outbound call to costumer to confirm information about the other two instances of this happening in the past month. Costumer was not reachable, therefore this agent will file an additional AE/PQC case; see case 02339639. No additional AEs/no additional PQCs. 21-FEB-2023 18:30 PM: Attachment added. 22-FEB-2022: Email containing images have been attached. Complaint Category Secondary Seal Missing / Incomplete: Cellophane Seal Not Present / Incomplete has been selected based on the narrative, "No, the product did not come with a cellophane cover". Agency will be notified to confirm the same and it may change post confirmation from agency. 22-FEB-2023: Second person review completed. 22-FEB-2023: Based upon the response received from the agency, the syringe trays are sealed with a cellophane cover, so the PQC category of Cellophane Seal Not Present / Incomplete will remain as it is. The complaint Description summary was also updated for category Cellophane Seal Not Present / Incomplete. Notification sent to agency regarding the confirmation o Complaint description summary. The communication has been attached in reference. 22-FEB-2023: Second person review completed.  Complaint Description Summary. The glass syringe surrounding the flange broke into two pieces while being administered to a patient. The product did not come with cellophane cover. ; Sender's Comments:  US-009507513-2302USA007278: US-009507513-2302USA007510: