Sex: U
Vaccine: HPV9
Symptoms: Skin laceration, Syringe issue
Clinical narrative: during the administration a piece of the finger flange broke off; and cut his finger; Description: Pharmacy technician reporting an AE and PQC associated with GARDASIL 9. Caller stated she was informed by her manager that "a couple of months ago" (exact date unknown by reporter) he was administering GARDASIL 9 to a patient and during the administration a piece of the finger flange broke off and cut his finger. Caller stated the patient receiving the GARDASIL 9 injection was not harmed and received the full dose of GARDASIL 9. Caller only provided the initials of her manager, but no additional demographics were provided. Caller stated her manager stated the syringe was disposed of after the administration was completed. Caller was unable to to provide the lot number, expiration date, or NDC number for the GARDASIL 9. Due to the syringe being discarded after administration it is not available for retrieval nor can the HCP send pictures. Caller stated her manager also informed her he heard this same situation happened to another HCP at a different location. Corresponding AE/PQC case 02150467 filed. No additional information provided. No additional AE or 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 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.) CALLER STATED THE FINGER FLANGE BROKE OFF WHILE THE HCP WAS INJECTING IT TO A PATIENT AND CUT THE HCP ON THE FINGER. THE PATIENT WAS UNHARMED.                 -Provide the exact location of the breakage on the syringe? FINGER FLANGE          -Does the syringe have a broken component? YES (broken finger flange)                 -If yes, describe in detail how it is broken. A PIECE OF THE FINGER FLANGE BROKE OFF AS THE HCP WAS INJECTING IT TO A PATIENT AND THE FINGER OF THE HCP WAS CUT                 -Provide the exact location of the breakage on the syringe? FINGER FLANGE                 -Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? NO          -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: NO                   -If not supplied by MERCK, what type & brand, needle size & gauge was used? UNKNOWN BY REPORTER  -Under what situation was this defect noticed: (select one)         -While the syringe was still in the tray? NO                 -If yes, is there product (liquid or dried residue) in the tray? N/A                 -Is there any broken glass or other separated component in the tray? NO          -After removing the syringe from the tray? NO          -While trying to attach the needle to the syringe? NO           -While giving the injection? YES           -Immediately after giving the injection? NO  -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?  *See below. YES         -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  -If complaint sample is not/cannot be returned, please provide reason: UNABLE TO OBTAIN AS THE PRODUCT WAS DISCARDED AFTER ADMINISTRATION  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: 20-APR-2022; Notification: Please confirm if the two following records are duplicates: 5004U00000xG68xQAC: 02150459, 02150462 and 5004U00000xG6AtQAK: 02150459, 02150467. 20-APR-2022: As the reported lot is unknown, we cannot identify the packaging site. Based on supply chain map, the packaging site could be. Hence two lead sites are assigned for this record. Upon lot receipt the record will be updated accordingly. 20-APR-2022 11:30 AM: Attachment added. 20-APR-2022 11:30 AM: Email request from quality: 5004U00000xG68xQAC: 02150459, to case owner for follow up. received on 20-APR-2022 at 7:33am with the following "Please confirm if the two following records are duplicates; 021 50462 and 5004U00000xG6AtQAK: 02150459, 02150467." See attachment. Forwarded 20-APR-2022 12:30 PM :The AE/ PQC's reported by the caller occurred at t wo different locations and involved two different HCP' s. Since t he caller had the initials of the manager that was cut by the broken finger flange at her facility the AE/PQC case (02150462) was filed. The second HCP's initials/name from the different location were unknown by the caller so the second AE/PQC case was filed (02150467) as their finger was a l so cut due to a broken finger flange. As two different AEs were reported involving a PQC and one s et of initials involved in the AE/ PQC was able to be provided that is the reason this agent opened two AE/ PQC cases for this call. Unfortunately, the caller did not have the lot number or expiration date of the GARDAS IL 9 syringes involved in the AE/ PQC' s or the dates for the AE onset date/ Date PQC was first identified. The caller was unable to confirm if these events involved the same GARDASIL 9 lot number and expiration date, so two cases were filed. Caller also stated she was unable to gather additional information during the initial call. 20-APR-2022; Second person reviewed