Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Syringe issue
Clinical narrative: No AE.; Sterile Injectable;N/A;Broken Syringe/Broken syringe; Nurse (also reported as a medical assistant) is calling in to report a PQC for GARDASIL 9. Per caller the finger flange is broken and dangling on the syringe. No AE.. QUESTION SECTION:   Medium Risk:  Broken Syringe Barrel High Risk:  Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange.   Notes for Agency:  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 "racked" 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? YES                 o If yes, describe the size, shape & depth of the crack: THE FINGER FLANGE IS CRACKED AND DANGLING ON THE SIDE                  o Provide the exact location of the crack on the syringe: THE FINGER FLANGE IS CRACKED WITH THE PIECE DANGLING ON THE SIDE OF IT          o Is the syringe broken into 2 or more pieces? NO                 o If yes, describe in detail how it is broken: (e.g. shattered, broken in half etc.) NA                  o Provide the exact location of the breakage on the syringe? NA           o Does the syringe have a broken component? YES/NO/NA/UNSPECIFIED (e.g. broken syringe tip; loose or detached luer lock, or broken finger flange) BROKEN FINGER FLANGE                  o If yes, describe in detail how it is broken. IT IS BROKEN ON THE SIDES WHERE THE FINGERS GO THERE IS A STRAIGHT BREAK LIKE A PERFECTLY ROUND SNAP                  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? NO          o Was there difficulty trying to attach the syringe needle to the syringe? NO                    o If yes, describe NA                    o If yes, was it supplied by MERCK: NA                     o If not supplied by MERCK, what type & brand, needle size & gauge was used? NA   o Under what situation was this defect noticed: (select one)         o While the syringe was still in the tray? NO                 o If yes, is there product (liquid or dried residue) in the tray? NA                  o Is there any broken glass or other separated component in the tray? (if yes specify) NA           o After removing the syringe from the tray? YES          o While trying to attach the needle to the syringe? NA            o While giving the injection? NA           o Immediately after giving the injection? NA o Was the syringe tip cap attached properly prior to use? YES           o If no, describe issue:  o Was the syringe tray intact and undamaged on receipt? YES         o If no, describe damage.  o If the product came with a cellophane cover, was the cellophane covering the syringe tray intact and completely sealed?  See below. YES         o If no, describe damage NA   o Was the syringe carton damaged prior to use?  (i.e. crushed, ripped, unglued) NO          o If yes, describe NA   o Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? NO  o If complaint sample is not/cannot be returned, please provide reason: NA   *If photos are available, ask the customer to send them to email.  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:  28-JUN-2022 19:30 PM :Attachment added to System.  28-JUN-2022 19:30 PM :Attachment added to System.  28-JUN-2022 19:30 PM :Email received in Contact Center on 28-JUN-2022 at 5:13pm with pictures for this case. See attached.  29-JUN-2022 Company representative: Received & attached Photos.  29-JUN-2022;  Second person reviewed by Company representative  29-JUN-2022 Company representative: Requested company to ask the reporter the following below- Can you please confirm with the reporter if the sample is available for return? If it is , Please send to company.  Also if it is not available can you ask them to provide the reason why.  29-JUN-2022 12:30 PM :Attachment added to System.  29-JUN-2022 12:30 PM :Email received on 29-JUN-2022 at 10:33am with the following request from quality: "Can you please confirm with the reporter if the sample is available for return? If it is , Please send to company.  Also if it is not available can you ask them to provide the reason why." See attached. Forwarded to case owner for follow up.  29-JUN-2022 15:00 PM :Attachment added to System.  29-JUN-2022 15:00 PM : Labels created  06/29/2022  29-JUN-2022 15:30 PM : Labels created  29-JUN-2022   29-JUN-2022 16:30 PM :Confirmed with caller at time of call that the product is available for return. No AE/no additional PQC details.  29-JUN-2022 16:30 PM :Case closed by mistake. Case reopened and submitted. No AE/additional PQC details.  Complaint Description Summary Per caller the finger flange is broken and dangling on the syringe.