Sex: U
Vaccine: HPV9
Symptoms: Syringe issue
Clinical narrative: no adverse event; one syringe is broken; Complaint Description Detail:  Procurement manager (caller) called to report that she was informed by their vaccine coordinator that one syringe of the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (NDC 00006412102) is broken. Caller does not have any information about the event. She does not know where the break is and other PQC details. Caller confirmed that it was discovered today 06-DEC-2022. She does not have the product at the time of the call, but provided the lot: W011455 ex 11-DEC-2024. Call will send the product back and provide pictures No AE reported; no additional PQC reported.  QUESTION SECTION: Medium Risk: Broken Syringe Barrel High Risk: Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange.  Notes for DPOC: - 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. - 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 question bellow: ONE SYRINGE IN THE PACKAGE IS BROKEN , CALLER DOES NOT KNOW WHERE ITS BROKEN FROM SINCE SHE DOES NOT HAVE THE PRODUCT WITH HER. - Is there a crack? UNKNOWN. - If yes, describe the size, shape & depth of the crack: UNKNOWN BY REPORTER. -Provide the exact location of the crack on the syringe: UNKNOWN BY REPORTER.  - Is the syringe broken into 2 or more pieces? UNKNOWN BY REPORTER, ONE SYRINGE IN THE PACKAGE IS BROKEN , CALLER DOES NOT KNOW WHERE ITS BROKEN FROM SINCE SHE DOES NOT HAVE THE PRODUCT WITH HER.  - If yes, describe in detail how it is broken: (e.g. shattered, broken in half etc.) UNKNOWN BY REPORTER. - Provide the exact location of the breakage on the syringe? UNKNOWN BY REPORTER.  -Does the syringe have a broken component? (e.g. broken syringe tip; loose or detached luer lock, or broken finger fiange) UNKNOWN BY REPORTER.  - If yes, describe in detail how it is broken. UNKNOWN BY REPORTER. - Provide the exact location of the breakage on the syringe? UNKNOWN BY REPORTER. - Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? UNKNOWN BY REPORTER. - Was there difficulty trying to attach the syringe needle to the syringe? N/A, PRODUCT WAS NOT USED. - If yes, describe N/A, PRODUCT WAS NOT USED. - 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: "NOTICED TODAY 06-DEC-2022 WHEN VACCINE COODINATOR WAS LOADING IT IN THE SYSTEM THAT IS WHEN SHE DISCOVERED IT. IT WAS NOT LOADED IN THE SYSTEM" SYSTEM WAS REFFERED TO IN REFERANCE TO POTENTIALLY INVENTORY DATA BASE.  -While the syringe was still in the tray? UNKNOWN BY REPORTER.  - Is there any broken glass or other separated component in the tray? (if yes specify) UNKNOWN BY REPORTER. - After removing the syringe from the tray? UNKNOWN BY THE CALLER. - While trying to attach the needle to the syringe? N/A, PRODUCT WAS NOT USED. - While giving the injection? N/A, PRODUCT WAS NOT USED. - Immediately after giving the injection? N/A, PRODUCT WAS NOT USED. - Was syringe tip cap attached properly prior to use? N/A, PRODUCT WAS NOT USED. - If no, describe issue: N/A, PRODUCT WAS NOT USED. - 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? "See below. UNKNOWN BY THE REPORTER. - If no, describe damage UNKNOWN BY THE REPORTER. - Was the syringe carton damaged prior to use? (i.e. crushed, ripped, unglued) UNKNOWN BY THE REPORTER. - If yes, describe N/A. - Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? NO. - If complaint sample is not/cannot be returned, please provide reason: CALLER WILL BE SENDING IT BACK.  - "If photos are available, ask the customer to send them PICTURES OF IT.  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:  06-DEC-2022 14:30: Attachment added.  06-DEC-2022 14:30: Waiting Retrieval site from Quality-- see attachment  06-DEC-2022 14:30: Attachment added.  06-DEC-2022 17:30: Attachment added.  06-DEC-2022 17:30: Email received in the Mailbox at 04:08 with a picture related to this case. See attached.  07-DEC-2022: [Anonymized: Received email contains photo and attachment. Same attached in record. As per photo review, finger flange is broken hence PQC category selected as "Broken Syringe /NA".  07-DEC-2022: Second Person review completed by [Anonymized].  07-DEC-2022 10:30: Retrieval site.  07-DEC-2022 10:30: Attachment added.  07-DEC-2022 10:30: Labels Created. Shipped on 07-DEC-2022.  07-DEC-2022: [Anonymized]: follow up email received and same attached.  Complaint Description Summary:  She was informed by their vaccine coordinator that one syringe of the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (NDC 00006412102) is broken.