Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Syringe issue
Clinical narrative: no adverse event; Sterile Injectable;N/A;Broken Syringe; Complaint Description Detail Merck Employee reporting adverse event pertaining to hepatitis a vaccine, inactivated(VAQTA). Merck Employee stated that Medical Assistant reported that facility received shipment of hepatitis a vaccine, inactivated(VAQTA) and 2/10 of the syringes were broken by the plunger. Merck Employee states that Medical Assistant was requesting replacement. No additional product quality complaints reported. No adverse events reported. No further details provided.   Immediate outbound call made to Medical Assistant to obtain additional product quality complaint information. No additional product quality complaints reported. No adverse events reported. No further details provided. QUESTION SECTION: Medium Risk: Stuck or Loose; Medium + Risk: Missing o QC Prefilled Syringe Device Plunger Rod and Stopper Irregularity Plunger or Stopper Fell out Missing Stuck Loose Damaged Bent Broken Medium Risk: Stuck or Loose o Medium + Risk: Missing    o Which irregularity occurred: (select one below) o Plunger rod (only) fell out of syringe barrel during use or is loose? No (if yes, specify which) o If the plunger rod fell out, confirm if the rubber stopper remained in the syringe barrel) o Plunger rod & stopper fell out of syringe barrel during use or is loose? No (if yes, specify which) o Plunger rod would not move? NA; Medical Assistant reports that plunger was not touched due to the plunger rod being broken o If yes, was resistance felt while pulling the plunger rod or pushing the plunger rod: (specify which)  o Plunger rod missing, i.e. not in the tray? No o Plunger rod & stopper missing? No o Plunger rod appeared to move without being touched? NA; Medical Assistant reports that plunger was not touched due to the plunger rod being broken o Plunger rod is damaged; bent; broken or discolored? Yes; Medical Assistant reports that the circular part of the plunger rod is broken.  o If yes, please describe defect in detail.  o Syringe stopper is damaged, malformed or discolored? No o If yes, please describe in detail. o Under which situation was this defect noticed: (select one below)  o While still in the tray? Yes o After removing the syringe from the tray &/or preparing the syringe for injection? NA o If yes, describe what actions were occurring when the defect happened. o While giving the injection? No o If yes, describe the actions occurring when defect happened or was noticed? o Was the syringe tray intact and undamaged on receipt? Yes o If no, describe damage. o 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 o Was the syringe carton damaged?  (i.e. crushed, ripped, unglued) No  o If yes, describe o Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? No o If complaint sample is not/cannot be returned, please provide reason:  o If photos are available, ask customers to send photos Retrieval Information: oObtain product (& tray if possible) 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: 09-AUG-2022 16:30 PM :Attachment added. 09-AUG-2022: The priority for this record has been changed per Product Quality Complaint, Complaint Category and Risk Priority Table. 09-AUG-2022: Requested photos and if product was available. 09-AUG-2022 18:30 PM: Attachment added.  09-AUG-2022 18:30 PM: Email received in the Contact Center Mailbox on 09-UAG-2022 at 5:20PM with the following request from Quality: "Please obtain photos and product if available." See attached. Forwarded to case owner for follow up. 09-AUG-2022 19:30 PM: case re-opened to check obtain box. No further details provided. 09-AUG-2022 19:30 PM: Customer stated that she will submit pictures and mail in complaint products when mailer was received. No further details provided. 10-AUG-2022; Second person reviewed.  10-AUG-2022 11:30 AM: Waiting for Retrieval Site from Quality-- See attachments  10-AUG-2022 11:30 AM: Attachment added.  10-AUG-2022: Attached email  10-AUG-2022 16:30 PM: Attachment added.