Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Syringe issue
Clinical narrative: the patient did not report any additionl adverse event; the finger flange shattered/ the flange shattered when the plunger end reached the flange; poor quality device used; Caller is a medical assistant reporting a PQC/AE for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe. Caller states that an LPN was administering a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) to a patient on 05-MAY-2022 when the finger flange shattered. Caller states the LPN informed her that the flange shattered when the plunger end reached the flange. Caller states patient received entire dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the patient did not report any additional AE. Caller was not able to provide full patient demographics at time of call. Caller provided consent to contact if necessary. See also AE case 02161154. QUESTION SECTION: Medium Risk : Broken Syringe Barrel High Risk: Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange. Notes for DPOC: 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 and 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. ) finger flange shattered - Provide the exact location of the breakage on the syringe? finger flange - Does the syringe have a broken component? NO (e. g. broken syringe tip; loose or detached luer lock, or broken finger flange) 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? NO (if yes describe) - 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 and brand, needle size and gauge was used? ' Under what situation was this defect noticed: (select one) during administration - While the syringe was still in the tray? NO - If yes, is there product (liquid or dried residue) in the tray? NO - Is there any broken glass or other separated component in the tray? (if yes specify) NO - 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? YES Was the syringe tip cap attached properly prior to use? YES - If no describe issue: Was t he syringe tray intact and undamaged on receipt? YES - If no, describe damage. If t he product came with a cellophane cover, was the cellophane covering the syringe tray intact and completely sealed? *See below. YES - If no, describe damage Was the syringe carton damaged prior to use? (i. e. crushed, ripped, unglued) NO - If yes, describe Was t he product administered or exposed to patient's bodily fluids (i.e. biohazardous)? YES If complaint sample is not/ cannot be returned, please provide reason: administering LPN put in sharps container , unable to be retrieved *If photos are available, ask the customer to send them Retrieval Information: Obtain product (and 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: 06-MAY-2022 14:30 :Attachment added. 03-MAY-2022; Second person reviewed