Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Syringe issue
Clinical narrative: broken finger flanges of GARDASIL 9 syringes.; no adverse event; Complaint Description Detail Healthcare provider was reporting product quality complaint regarding 2 broken finger flanges of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) syringes. Caller would send photos to the mailbox and the product was available for retrieval. No AE reported. No additional PQC reported.  NDC 0006412101 (individual syringe) NdC 0006412102 (10 In BOX) Lot: U031051 EXP: 14-JUN-2024  QUESTION SECTION: Medium Risk: Broken Syringe Barrel High Risk: Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange.  Notes: 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: NOT APPLICABLE                    Provide the exact location of the crack on the syringe: NOT APPLICABLE          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 FINGER FLANGE WAS BROKEN OFF AND HANGING LOOSE.                    Provide the exact location of the breakage on the syringe? THE RING OF THE FINGER FALANGE HAS SEPARATED FROM THE BODY.          Does the syringe have a broken component? YES. BROKEN FINGER FLANGE                  If yes, describe in detail how it is broken . THE RING OF THE FINGER FLANGE HAD SEPARATED FROM THE BODY OF THE SYRINGE.          Provide the exact location of the breakage on the syringe? THE RING OF THE FINGER FLANGE HAD SEPARATED FROM THE BODY OF THE SYRINGE.          Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? NOT APPLICABLE Was there difficulty trying to attach the syringe needle to the syringe? NOT APPLICABLE             If yes, describe NOT APPLICABLE             If yes, was it supplied by MERCK: NOT APPLICABLE            If not supplied by MERCK, what type & brand, needle size & gauge was used?'NOT APPLICABLE Under what situation was this defect noticed: (select one) WHEN THE PACKAGE WAS OPENED              While the syringe was still in the tray? YES                            If yes, is there product (liquid or dried residue) in the tray? NO                            Is there any broken glass or other separated component in the tray? (if yes specify) NO              After removing the syringe from the tray? YES              While trying to attach the needle to the syringe? NOT APPLICABLE              While giving the injection? NOT APPLICABLE              Immediately after giving the injection? NOT APPLICABLE Was the syringe tip cap attached properly prior to use?NOT APPLICABLE           If no, describe issue: NOT APPLICABLE Was the syringe tray intact and undamaged on receipt? YES          If no, describe damage. If the product came with a cellophane cover, was the cellophane covering the syringe tray intact and completely sealed? YES osee below.        If no, describe damage: NOT APPLICABLE Was the syringe carton damaged prior to use? (i.e. crushed, ripped, unglued) NO DAMAGE        If yes, describe: NOT APPLICABLE Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? NOT ADMINISTERED If complaint sample is not/cannot be returned, please provide reason: PRODUCT WAS AVAILABLE FOR RETURN. oIf 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:  19-OCT-2022 18:30 PM :Attachment added. 19-OCT-2022 18:30 PM :Attachment added. 19-OCT-2022 18:30 PM :Email received in the Contact Center Mailbox on 19-OCT-2022 at 4:18pm with pictures related to this case. See attached. 20-OCT-2022:  Received email was unable to attached since it was big file. Hence photos and attachment were saved separately. Same was attach. 20-OCT-2022; Second person reviewed  20-OCT-2022 12:30 PM :Waiting for Retrieval Site from Quality  20-OCT-2022 12:30 PM :Attachment added  20-OCT-2022 15:30 PM :Label created ON 20-OCT-2022   Complaint Description Summary Healthcare provider was reporting product quality complaint regarding 2 broken finger flanges of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) syringes.