Sex: F
Vaccine: HEPA
Symptoms: Skin laceration, Syringe issue
Clinical narrative: cut the Nurse on their hand; the syringe stopper broke; injury associated with device; This spontaneous report was received from a nurse, referring to a 31-year-old female, fellow nurse.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 15-NOV-2023, the nurse administered a dose of hepatitis a vaccine, inactivated (VAQTA) (route and dosage information was unknown; lot # X004814 expiration date 10-OCT-2024) to a pediatric patient with no issue.  As the nurse went to apply the safety mechanism over the needle, the syringe stopper broke and cut the nurse on their hand (laceration of hand). The nurse had a band aid placed over the cut.  The syringe was available to be retrieved for evaluation and pictures were taken of the broken syringe.    The outcome of laceration of hand was reported as recovered on 15-NOV-2023.  The causality assessment between the adverse event and the suspect vaccine was not provided.   Nurse calling to report AE/PQC regarding a VAQTA syringe. Reporting Nurse stated that a fellow Nurse was involved in this event. Nurse stated that the dose of hepatitis a vaccine, inactivated (VAQTA) was administered to a pediatric patient with no issue, but as the Nurse went to apply the safety mechanism over the needle, the syringe stopper broke and cut the Nurse on their hand. Reporting Nurse confirmed no harm came to the patient involved, but the Nurse who administered the injection cut their hand and had a band aid placed over the cut. Reporting Nurse stated that the syringe is available to be retrieved for evaluation and pictures were taken of the broken syringe. Provided Nurse with email address to send pictures. The Nurse who cut their hand on the broken syringe stopper stated that they do not currently have a Primary Care Physician and refused correspondence. No additional information provided regarding this Adverse Event and PQC. Case number provided. No additional AE or PQC reported.   QUESTION SECTION: For CSR: 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 o If the plunger rod fell out, confirm if the rubber stopper remained in the syringe barrel) N/A o Plunger rod & stopper fell out of syringe barrel during use or is loose? NO o Plunger rod would not move? NO o If yes, was resistance felt while pulling the plunger rod or pushing the plunger rod: (specify which) N/A 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? NO o Plunger rod is damaged; bent; broken or discolored? NO o If yes, please describe defect in detail. N/A o Syringe stopper is damaged, malformed or discolored? YES o If yes, please describe in detail. SYRINGE STOPPER BROKE AFTER COMPLETING INJECTION TO PEDIATRIC PATIENT WHILE APPLYING SAFETY MECHANISM AND CUT NURSE'S HAND, NO DIFFICULTY PLUNGING SYRINGE REPORTED o Under which situation was this defect noticed: (select one below) o While still in the tray? NO o After removing the syringe from the tray &/or preparing the syringe for injection? NO o If yes, describe what actions were occurring when the defect happened. N/A o While giving the injection? AFTER GIVING INJECTION o If yes, describe the actions occurring when defect happened or was noticed? AFTER INJECTION WAS COMPLETE, THE SYRINGE STOPPER BROKE AND CUT THE NURSE'S HAND o Was the syringe tray intact and undamaged on receipt? YES o If no, describe damage. N/A 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 N/A o Was the syringe carton damaged? (i.e. crushed, ripped, unglued) NO o If yes, describe N/A o Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? PRODUCT WAS ADMINISTERED PRIOR TO DEFECT OCCURENCE ON THE SYRINGE STOPPER, NO HARM TO PATIENT OCCURRED, NURSE CUT THEIR HAND ON BROKEN SYRINGE STOPPER o If complaint sample is not/cannot be returned, please provide reason: YES, SYRINGE IS AVAILABLE TO BE RETRIEVED o If photos are available, ask customers to send photos to Merck. PICTURES ARE ATTACHED TO THIS CASE SENT BY THE REPORTING NURSE 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: 15-NOV-2023 17:30 PM :Attachment added to Service. 15-NOV-2023 17:30 PM :Email received to inbox on 15-NOV-2023 at 1548 with pictures of the affected product. See attached. 15-NOV-2023 17:30 PM :Attachment added to Service.  16-NOV-2023 : The category of Broken Syringe- Flange - broken during and after injection was assigned as complainant reported that Nurse stated that the dose of VAQTA was administered to a pediatric patient with no issue, but as the Nurse went to apply the safety mechanism over the needle, the syringe stopper broke (flange part Broken) and cut the Nurse on their hand. The received images shows that the flange part was broken. The images have been received and attached in reference. 16-NOV-2023: Second person review done.