Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Syringe issue
Clinical narrative: No adverse event; Sterile Injectable;N/A;Broken Syringe; Complain Description Detail:  Caller was a medical assistant (also reported as "nurse") reporting a broken hvp rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe. Caller states upon receipt of a tray of 10 pre-filled syringes, 1 syringe was broken in the tray. Caller states product was not able to be retrieved because it was disposed of in the sharps container when it was discovered. No additional information available. No patient involvement, no additional AE/PQC reported.  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 had 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.  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? NO 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.) BROKEN IN PIECES INSIDE TRAY  Provide the exact location of the breakage on the syringe?  BARREL Does the syringe have a broken component? NO (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? NO (if yes describe) Was there difficulty trying to attach the syringe needle to the syringe? NA  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  If yes, is there product (liquid or dried residue) in the tray? YES  Is there any broken glass or other separated component in the tray? (if yes specify) After removing the syringe from the tray? NO While trying to attach the needle to the syringe? NO While giving the injection? NO Immediately after giving the injection?  Was the syringe tip cap attached properly prior to use? NA If no, describe issue: Was the syringe tray intact and undamaged on receipt? NO If no, describe damage. STRINGE WAS BROKEN INSIDE TRAY UPON RECEIPT 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 Was the syringe carton damaged prior to use?  (i.e., crushed, ripped, unglued) NO If yes, describe Was the product administered or exposed to patient's bodily fluids (i.e., biohazardous)? NO If complaint sample is not/cannot be returned, please provide reason: EMPLOYEE DISCARDED IN SHARPS CONTAINER, RETRIEVAL NOT POSSIBLE 06-MAY-2022: Reporter - The priority for this record has been changed per Product Quality Complaint, Complaint Category and Risk Priority Table. 06-MAY-2022; Second person reviewed  06-MAY-2022: Report - Attached email  Complaint Description Summary Medical assistant reporting a broken hvp rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe in the tray.