Sex: U
Vaccine: HPV9
Symptoms: Syringe issue
Clinical narrative: the glass syringe surrounding the flange broke into two pieces while being administered to a patient; No additional AEs/no additional PQCs; Complaint Description Detail 22-FEB-2023: Note: PR#381784 (Case number - 02339389) has been created for a Lot number W021492 having a same defect. The linked report bearing PR#381785 (Case number - 02339639) has been created or an unknown lot number. Healthcare professional (HCP) reporting that they have been experiencing issues with their HPV RL1 6 11 16 18 31 33 45 52 58 VLP VACCINE (YEAST) (GARDASIL 9) syringes. HCP reports that the glass syringe surrounding the flange broke into two pieces while being administered to a patient; an AE was filed in case 02339389. HCP also states that there have been two other instances within the last month where HPV RL1 6 11 16 18 31 33 45 52 58 VLP VACCINE (YEAST) (GARDASIL 9) syringes have been possibly broken and possibly administered. A precautionary AE/PQC is being filed because it can not be ruled out unknown broken HPV RL1 6 11 16 18 31 33 45 52 58 VLP VACCINE (YEAST) (GARDASIL 9) syringes being used on a patient in the past. No further information was provided to further clarify any details or a timeline of events. Consent to contact the HCP was provided. No additional AEs/no additional PQCs.  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/NO/NA/UNSPECIFIED If yes, describe in detail how it is broken: (e.g. shattered, broken in half etc.) Provide the exact location of the breakage on the syringe? 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) If yes, describe in detail how it is broken. Provide the exact location of the breakage on the syringe? Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? YES/NO/NA/UNSPECIFIED (if yes describe) Was there difficulty trying to attach the syringe needle to the syringe? YES/NO/NA/UNSPECIFIED 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/NO/NA/UNSPECIFIED Was the syringe tip cap attached properly prior to use? YES/NO/NA/UNSPECIFIED If no, describe issue: Was the syringe tray intact and undamaged on receipt? YES/NO/NA/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. YES/NO/NA/UNSPECIFIED If no, describe damage Was the syringe carton damaged prior to use? (i.e. crushed, ripped, unglued) YES/NO/NA/UNSPECIFIED If yes, describe Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? YES/NO/NA/UNSPECIFIED If complaint sample is not/cannot be returned, please provide reason: If photos are available, ask the customer to send them to email 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: Unknown Insertion Difficulty: Insertion Difficulty Details: Doubt About Presence: Doubt Details: Migration: Migration Details: Removal Problem: Removal Problem Details: 21-FEB-2023 18:30 PM: Attachment added to System. 22-FEB-2023:  - Agency will be notified to provide images and Lot number. - Complaint category has been selected based on the narrative and may change post updated information/images received. - Mfg and Pkg sites have been selected since lot number is unknown and may change post confirmation received from the sites. - Number of occurrences have been taken as 2 since complainant has stated that the defect was observed twice before the current one. 22-FEB-2023: Second person review completed; e-sign to be performed 22-FEB-2023 12:30 PM: Attachment added to System. 22-FEB-2023 12:30 PM: Email received in the Mailbox on 22-FEB-2023 at 11:26am with the following request from quality: "Dear Agency, - provide images and Lot number" See attached. Email forwarded to case owner for follow up. Complaint Description Summary HCP reports that the glass syringe surrounding the flange broke into two pieces while being administered to a patient ; Sender's Comments:  US-009507513-2302USA007601: