Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Syringe issue
Clinical narrative: No additional AE reported.; the finger flanges broke off the syringe during administration.; the patient did received the full dose of GARDASIL 9; Complaint Description Detail: Caller is a medical assistant calling to report an adverse event and product quality complaint for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). Caller reports that another medical assistant in the office was administering a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and stated that the finger flanges broke off the syringe during administration. Caller reports that the patient did received the full dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), and there was no injury to the patient at all. Caller reports that the broken barrel of the syringe injured the medical assistant during administration and stated that the syringe "sliced the medical assistants fingers". Caller reports that the broken HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) syringe was discarded, and would not be able to obtained to send back to Merck. No additional information provided. Additional AE/PQC filed in 02236404 for the medical assistant that sustained injury from the broken syringe of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) reported in this case. No additional AE reported. No additional PQC reported. QUESTION SECTION: Medium Risk: Broken Syringe Barrel High Risk: Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange. Notes for agencies:  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.) The syringe barrel broke in half  Provide the exact location of the breakage on the syringe? The portion of the barrel where the finger flange is attached broke off the syringe. Does the syringe have a broken component? YES (e.g. broken syringe tip; loose or detached luer lock, or broken finger flange) f yes, describe in detail how it is broken. The finger flanges broke off the syringe barrel Provide the exact location of the breakage on the syringe? Toward the end of the syringe where the finger flanges are located.  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: N/A If not supplied by MERCK, what type & brand, needle size & gauge was used?' N/A 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? NIA Is there any broken glass or other separated component in the tray? NIA 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: NIA Was the syringe tray intact and undamaged on receipt? YES If no, describe damage. NIA 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 NIA 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: The syringe was discarded, and not able to be retrieved.  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:  30-AUG-2022 17:30 : Attachment added. 30-AUG-2022 17:30 : HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) retrieval will not occur as the customer stated that the product has been discarded. 31-AUG-2022 Company employee: Requested to please confirm 02236367/ 02236404?  31-AUG-2022 10:30 :Attachment added. 31-AUG-2022 10:30 : Email received in the PQC Mailbox on 31-AUG-2022 at 8: 42am from quality stating: "Can you please confirm if: 02236367/ 02236369 is a duplicate of: 02236367/ 02236404?" See attached. Email forwarded to case owner for further handling. 31-AUG-2022 12:30 : Clarification received from quality to confirm if this case is a duplicate of 02236404. This agent can confirm that the PQC information reported for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) in case 02236404 is a duplicate of this case (02236369). This agent filed a AE/PQC case to reflect the adverse event for 2 different patient's with the same HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) involved in PQC. No additional information. No new AE or PQC reported. 31-AUG-2022 Company Employee: Requested to please confirm how many syringes were broken and if the reporter has photos, since an AE was filed because of 2 different patients  31-AUG-2022; Second person reviewed 31-AUG-2022 14:30 :Attachment added. 31-AUG-2022 14:30 :Email received in the PQC Mailbox on 31Aug2022 at 13:47 pm with the following message from quality: "02236367/ 02236404 Hi,  This record will be closed as a duplicate of; 02236367/ 02236369.  Thanks,  Company Emplyee: See attachment. Forward to case owner.  31-AUG-2022 14:30 :Attachment added. 31-AUG-2022 14: 30 : Email 1 received in the PQC Mailbox on 31Aug2022 at 13:43 pm with the following message from quality: "Urgent request: 02236367/ 02236404 and 02236367/ 02236369  Hi,  Can you please confirm how many syringes were broken and if the reporter has photos, since an AE was filed because of 2 different patients?  Thanks,  Company Employee  See attachment. \ forward to case owner.  31-AUG-2022 15:30 :Clarification received from quality. There was only 1 syringe of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) affected for this PQC. The HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) syringe that was being administered to the patient broke during administration and injured the medical assistant that was administering it to the patient. The customer was not able to provide this agent with photographs of the broken syringe of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), as she stated that it had been discarded in the biohazard container at the time of the initial call. No additional information provided. No new AE or PQC. 31-AUG-2022 17:30 :Attachment added. 31-AUG-2022 17:30 :Attachment added. 01-SEP-2022 10:30 : Per Agent, product does not need to be retrieved. Mail team task has been cancelled 01-SEP-2022 Company Employee: Received & Attached failure- No Missing info added 02-SEP-2022 Company Employee: Received & Attach email.  Complaint Description Summary  Reporter stated that the finger flanges broke off the syringe during administration. ; Sender's Comments:  US-009507513-2208USA011721: