Sex: U
Vaccine: HPV9
Symptoms: Syringe issue
Clinical narrative: During the administration a piece of the finger flange broke off and cut the HCP's finger; During the administration a piece of the finger flange broke off and cut the HCP's finger/Broken Syringe; Complain Description Detail:  Pharmacy technician reporting an AE and PQC associated with hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9).  Caller stated her manager informed her that an HCP (name unknown by reporter) was administering hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) to a patient and during the administration a piece of the finger flange broke off and cut the HCP's finger. Caller stated the severity of the cut was unknown. Caller stated her manager stated this situation occurred "a couple months ago" and did not have an exact date. Caller stated her manager stated the patient receiving the hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection was not harmed and received the full dose of hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). Caller stated this situation occurred at a different location and she was provided limited details by her manager. Caller stated she does not know the lot number, expiration date, or NDC number. Caller unable to provide pictures nor is the product available for retrieval as this event occurred "a couple months ago". Caller did not provide demographics for her manager. 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:  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? UNKNOWN BY REPORTER o If yes, describe the size, shape & depth of the crack: UNKNOWN BY REPORTER o Provide the exact location of the crack on the syringe: UNKNOWN BY REPORTER 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.) 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 o Provide the exact location of the breakage on the syringe? FINGER FLANGE o Does the syringe have a broken component? YES (broken finger flange) o If yes, describe in detail how it is broken. CALLER STATED THE FINGER FLANGE BROKE OFF WHILE THE HCP WAS INJECTING IT TO A PATIENT 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? UNKNOWN BY REPORTER o Was there difficulty trying to attach the syringe needle to the syringe? UNKNOWN BY REPORTER 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? UNKNOWN BY REPORTER o If yes, is there product (liquid or dried residue) in the tray? UNKNOWN BY REPORTER o Is there any broken glass or other separated component in the tray? (if yes specify) UNKNOWN BY REPORTER o After removing the syringe from the tray? UNKNOWN BY REPORTER o While trying to attach the needle to the syringe? UNKNOWN BY REPORTE o While giving the injection? UNKNOWN BY REPORTER o Immediately after giving the injection? UNKNOWN BY REPORTER o Was the syringe tip cap attached properly prior to use? UNKNOWN BY REPORTER o If no, describe issue: N/A o Was the syringe tray intact and undamaged on receipt? UNKNOWN BY REPORTER 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 BY REPORTER o If no, describe damage N/A o Was the syringe carton damaged prior to use?  (i.e. crushed, ripped, unglued) UNKNOWN BY REPORTER  o If yes, describe N/A o Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? YES o If complaint sample is not/cannot be returned, please provide reason:  UNABLE TO OBTAIN AS THE PRODUCT WAS DISCARDED AFTER ADMINISTRATION  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 Insertion Difficulty:  Insertion Difficulty Details:  Doubt About Presence:  Doubt Details:  Migration:  Migration Details:   Removal Problem:   Removal Problem Details: 20-APR-2022; Notification to agency. Please confirm if the two following records are duplicates; 5004U00000xG68xQAC:02150459, 02150462 and 5004U00000xG6AtQAK:02150459, 02150467.  20-APR-2022 12:30 PM: The AE/PQC's reported by the caller occurred at two different locations and involved two different HCP's. Since the caller had the initials of the manager that was cut by the broken finger flange at her facility the AE/PQC case 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 as their finger was also cut due to a broken finger flange. As two different AEs were reported involving a PQC and one set 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 GARDASIL 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:  As the reported lot is unknown, we cannot identify the packaging site.  Based on supply chain map, the packaging site.  Hence two lead sites are assigned for this record. Upon lot receipt the record will be updated accordingly. 20-APR-2022; Second person reviewed 20-APR-2022: Received & attached failure- No Missing info added.