Sex: U
Vaccine: HPV9
Symptoms: Syringe issue
Clinical narrative: No additional AEs were reported; the patient received the vaccine with a GARDASIL 9 syringe with PQC issue; the patient received the vaccine with a GARDASIL 9 syringe with PQC issue; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information on pertinent medical history, concomitant medications or drug reactions and allergies  On 10-APR-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis, lot #W026977, expiration date 04-JAN-2025 (it was reported that this is the correct and only lot number that had the issue. The lot number that was reported initially (# W011455) was incorrect)) (exact dose and injection site were not provided).  After the vaccine was given to a patient, the vaccine's "handle" was broken. The pharmacist could not clarify what it meant by "handle", but she thought it might be the finger flange (syringe issue, poor-quality device used). The packaging was all intact (no broken seals or tears) when initially opened. The barrel flange completely broke off when administering the drug. The product was discarded, and no photos were taken. No additional adverse events (AEs) were reported.  This is a non-valid case due to lack of patient's identifiers  Complaint Description Detail  Pharmacist called to report AE/PQC with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) GARDASIL 9 syringe. According to the pharmacist, after hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was given to a patient, the vaccine's "handle" was broken. The pharmacist could not clarify what it meant by "handle", but she thinks it might be the finger flange. AE was filed as precaution because the patient received the vaccine with a hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) syringe with PQC issue. The pharmacist did not have much information about the incident including photo and retrieval information so she will have another pharmacist call back to answer the PQC questions. No additional PQC/AEs were reported. No further information provided.  QUESTION SECTION: Medium Risk: Broken Syringe Barrel High Risk: Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange.  Notes for Agency: 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? YES/NO/NA/UNSPECIFIED If yes, describe the size, shape & depth of the crack: Provide the exact location of the crack on the syringe: 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.) UNSPECIFIED Provide the exact location of the breakage on the syringe? "HANDLE" OR POSSIBLY FINGER FLANGE Does the syringe have a broken component? YES (e.g., broken syringe tip; loose or detached luer lock, or broken finger flange) POSSIBLY "FINGER FLANGE" If yes, describe in detail how it is broken. IT WAS BROKEN AFTER THE VACCINATION Provide the exact location of the breakage on the syringe? FINGER FLANGE OR "HANDLE" Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? UNSPECIFIED (if yes describe) Was anyone injured as a result of the breakage? NO If yes, provide brief description of injury Note to Agency: Report an AE if yes as outlined in Instruction section Was there difficulty trying to attach the syringe needle to the syringe? NO If yes, describe If yes, was it supplied by MERCK: YES/NO/NA/UNSPECIFIED If not supplied by MERCK, what type & brand, needle size & gauge was used? ' Under what situation was this defect noticed: (select one) While the syringe was still in the tray? YES/NO/NA/UNSPECIFIED If yes, is there product (liquid or dried residue) in the tray? YES/NO/NA/UNSPECIFIED Is there any broken glass or other separated component in the tray? (If yes specify) After removing the syringe from the tray? YES/NO/NA/UNSPECIFIED While trying to attach the needle to the syringe? YES/NO/NA/UNSPECIFIED While giving the injection? YES/NO/NA/UNSPECIFIED Immediately after giving the injection? YES Was the syringe tip cap attached properly prior to use? UNSPECIFIED If no, describe issue: Was the syringe tray intact and undamaged on receipt? UNSPECIFIED If no, describe damage. 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 Was the syringe carton damaged prior to use? (i.e., crushed, ripped, unglued) UNSPECIFIED If yes, describe 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: UNKNOWN IF THE SAMPLE IS AVAILABLE. *If photos are available, ask the customer to send them to email UNKNOWN IF PHOTO CAN BE SENT IN. 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: Not Applicable Insertion Difficulty Details: Not Applicable Doubt About Presence: Not Applicable Doubt Details: Not Applicable Migration: Not Applicable Migration Details: Not Applicable Removal Problem: Not Applicable Removal Problem Details: Not Applicable 13-APR-2023 14:30 PM: Attachment added to Service Cloud. 14-APR-2023 Anonymized: Agency has been requested for the complained product photographs and to confirm if the sample is available for return. Since the reporter stated that 'After hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was given to a patient, the vaccine's "handle" was broken' and the pharmacist thinks it might be the finger flange, the PQC category 'Broken Syringe > Broken During or After injection' has been selected. 14-APR-2023 Anonymized: Second Person Review completed. 14-APR-2023 10:30 AM: Attachment added. 14-APR-2023 10:30 AM: Email received in the Mailbox on 13-APR-2023 at 7:10am with additional information for this case. See attached. Forwarded to case owner for awareness. 14-APR-2023 10:30 AM: Attachment added. 14-APR-2023 10:30 AM: Email received in the mailbox on 14-APR-2023 at 12:29am with the following request from quality: "Please provide the complained product photographs and confirm if the sample is available for return.  Since the reporter stated that after hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was given to a patient, the vaccine's "handle" was broken', please confirm if the finger flange was broken." See attached. Forwarded to case owner for follow up.  14-APR-2023 12:30 PM: Responding to Quality's inquiry. A response from the pharmacist was attached to this case. Please see attachment. This case will be closed since no product will be returned.  Complaint Description Summary  After hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was given to a patient, the vaccine's "handle" was broken. The pharmacist thinks it might be the finger flange.