Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Syringe issue
Clinical narrative: No adverse event; Broken VAQTA PFS/ Broken Syringe Barrel/ Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange; Caller reports one broken Hepatitis A vaccine, inactivated(VAQTA) pre-filled syringe (PFS). No adverse event (AE) or additional PQCs reported. Caller would send pictures and hold product for return. QUESTION SECTION: Medium Risk: Broken Syringe Barrel, High Risk: Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange. Notes for DPOC: Please provide a detailed description of the defect using the questions below: Is there a crack? NO o If yes, describe the size, shape & depth of the crack: NA o Provide the exact location of the crack on the syringe: NA; 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.) Tip is broken off o Provide the exact location of the breakage on the syringe? Tip - leur-lock is broken off o Does the syringe have a broken component? YES (e.g. broken syringe tip; loose or detached leur-lock, or broken finger flange) o If yes, describe in detail how it is broken: Leur-lock is broken off o Provide the exact location of the breakage on the syringe? Tip below Leur-lock o Is the tip of the syringe or Luer-lock adaptor loose or broken off of the syringe tip? YES (if yes describe): Broken Off o Was there difficulty trying to attach the syringe needle to the syringe? NA o If yes, describe NA o If yes, was it supplied by MERCK: NA o If not supplied by MERCK, what type & brand, needle size & gauge was used?' NA Under what situation was this defect noticed: (select one) o While the syringe was still in the tray? YES; If yes, is there product (liquid or dried residue) in the tray? YES o Is there any broken glass or other separated component in the tray? (if yes specify) Yes o After removing the syringe from the tray? NO; While trying to attach the needle to the syringe? NO o While giving the injection? NO; Immediately after g1v1ng the injection? NO; Was the syringe tip cap attached properly prior to use? NA o If no, describe issue: Was the syringe tray intact and undamaged on receipt? YES o 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 o If no, describe damage; Was the syringe carton damaged prior to use? (i.e. crushed, ripped, unglued) NO o 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: Caller will save for return; 18-NOV-2021, attached email and embedded pictures in a PDF file as well. See attachments. No new PQC. No additional information; 18-NOV-2021, based on the review of the PQC the priority for this record had been changed per Product Quality Complaint, Complaint Category and Risk Priority Table; 18-NOV-2021; Second person reviewed; 18-NOV-2021, at 15:30: Attachment added to Service Cloud; 18-NOV-2021 at 15:30: UPS Labels created Shipped on 18-NOV-2021; 19-NOV-2021: Second person reviewed performed for follow up activity.