Sex: U
Vaccine: HPV9
Symptoms: Syringe issue
Clinical narrative: No adverse event; syringe flange broke into 3 different pieces. Caller mentioned that they have this issue often with GARDASIL 9 breaking or cracking; always seems like the syringes are out of place like the holder itself is not holding them in; Complaint Description Detail  14-OCT-2022: Employee, this record was created to log unknown lots. Lot U031056 was logged.  Caller reported they have had this issue often with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). Caller reported no patient's actually injured, but that the nurse was cut while removing the syringe from the box. Not able to send mailer for retrieval. Caller reported sometimes the products were broken in the box they come in and sometimes the issue happens later. For this product quality complaint (PQC) caller stated it was noticed later after when they went to take it out to use.  "Per caller when they open a new package of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and it always seems that the actually syringes in the packaging were always loose. Caller reported it always seems like the syringes were out of place like the holder itself was not holding them in place. Caller thinks that maybe why they were having so many syringes break." PQC 02268045. No other adverse events (AE's) reported. Question section: Medium risk: broken syringe barrel High risk: cracked or broken luer lock (needle attachment issues), broken finger flange.  Notes for RA: A cracked syringe has a line or chip in the glass, but the syringe was essentially intact in one piece. A syringe was considered broken when the syringe was in 2 or more pieces. Customer report that the product was broken in the box, but not upon shipment it happened later. A syringe was 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? Not applicable (NA) If yes, describe the size, shape & depth of the crack: NA Provide the exact location of the crack on the syringe: NA  Is the syringe broken into 2 or more pieces? yes If yes, describe in detail how it was broken: (e.g. shattered, broken in half etc.) broken Provide the exact location of the breakage on the syringe? Caller was not sure how many, but reported they would be able to send pictures.  Does the syringe have a broken component? yes (broken finger flange) If yes, describe in detail how it was broken. reported they would send pics Provide the exact location of the breakage on the syringe? per caller it happened in the flange part Is the lip of the syringe or luer lock adaptor loose or broken off of the syringe lip? NA  Was there difficulty trying to attach the syringe needle to the syringe? NA If yes, describe: NA If yes, was it supplied by MERCK: NA If not supplied by MERCK, what type & brand, needle size & gauge was used? NA  Under what situation was this defect noticed: (select one) Per caller for this time it was noticed when they went to get one out of the box to use. While the syringe was still in the tray? yes If yes, was there product (liquid or dried residue) in the tray? Per caller it did not leak. Just the flange was broken Was there any broken glass or other separated component in the tray? caller stated that it was separated but they were not sure how many since they were not at the site it happened. After removing the syringe from the tray? NA While trying to attach the needle to the syringe? NO While giving the injection? No Immediately after giving the injection? No Was the syringe tip cap attached properly prior to use? NA If no, describe issue: NA Was the syringe tray intact and undamaged on receipt? Caller reported that the syringes in the tray looked loose. If no, describe damage. Caller said it was not necessarily damaged just seemed like the tray did not hold the product in place when it was being transported.  If the product came with a cellophane cover, was the cellophane covering the syringe tray intact and completely sealed? See below. Unspecified If no, describe damage: unknown  Was the syringe carton damaged prior to use? (i.e. crushed, ripped, unglued) no If yes, describe NA  Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? No  If complaint sample was not/cannot be returned, please provide reason: No discarded caller can send pic's If photos were available, ask the customer to send them to (anonymized information). Retrieval Information: Obtain product (& tray if possible) Expedite return for cracked syringes. If there was a doubt whether it was 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  14-OCT-2022 14:30 post meridiem (pm): attachment added to system.  14-OCT-2022 14:30 PM: email received in the mailbox on 14-OCT-2022 at 12:30 pm with photos from the customer of this case. See attached.  14-OCT-2022: employee, photos received and attached  14-OCT-2022: employee, this category (dissembled upon opening was used since there was no category available. 14-OCT-2022: second person reviewed by employee.  14-OCT-2022 16:30 pm: PQC 02268353 filed after receiving the email attached to this case as it was noted in the body of the email: "We continually were seeing broken syringes that were arriving in their original small packaging". See attachment.  14-OCT-2022 17:30 pm: attachment added to system.  14-OCT-2022 17:30 pm: email received in the mailbox on 14-OCT-2022 at 12:16pm from the customer with correspondence related to the AE in this case. See attached.  14-OCT-2022 18:30 pm: new cases were opened to add additional attachments. See cases 02268581 and 02268577. No additional AE/PQC reported. No additional information provided.  17-OCT-2022: employee additional Complaint Category added to Reported & Investigated PQC Categories based on follow up received in case 02268045 (PR 372905) stating "Caller reported he can send a picture from these issues where the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) syringe flange broke into 3 different pieces. Caller mentioned that they have this issue often with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) breaking or cracking."  17-OCT-2022: Second person reviewed by employee  17-OCT-2022: employee- additional device code added for cracked syringe. 17-OCT-2022: second person reviewed by employee  17-OCT-2022: employee- email sent to agency and employee with attachment photo and video that could not be added to this record.  Complaint description summary Caller mentioned sometimes the products were broken in the box they come in and sometimes the issue happens later. And seems that the actual syringes in the packaging were always loose. ; Sender's Comments:  US-009507513-2210USA005617: US-009507513-2210USA005747: