Sex: U
Vaccine: HEPA
Symptoms: Syringe issue
Clinical narrative: No adverse event; a piece of the barrel flange broke; Nurse reporting product quality complaint pertaining to hepatitis a vaccine, inactivated (VAQTA) along with adverse event. Nurse reports that another Nurse was administering hepatitis a vaccine, inactivated (VAQTA) to a patient and while pushing the plunger to the barrel flange, a piece of the barrel flange broke and a shard of glass broke through the administering Nurse's glove and cut her finger. Nurse reports that patient was not injured during the administration of hepatitis a vaccine, inactivated (VAQTA).   Please reference case number 02129514 for adverse event documentation pertaining to the administering Nurse.   Nurse reports that pictures were submitted to her quality department and she will will attempt to obtain pictures and submit them to Agency.   No additional information provided. No additional adverse events reported. No additional product quality complaints reported. No further details provided. QUESTION SECTION: Medium Risk: Broken Syringe Barrel High Risk: Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange.  Notes for Agency:  o 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. o 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).  o Please provide a detailed description of the defect using the questions below:        o Is there a crack? No                 o If yes, describe the size, shape & depth of the crack:                 o Provide the exact location of the crack on the syringe:         o Is the syringe broken into 2 or more pieces? Yes                 o If yes, describe in detail how it is broken: (e.g. shattered, broken in half etc.)                 o Provide the exact location of the breakage on the syringe? Nurse was administering hepatitis a vaccine, inactivated (VAQTA) to a patient and while pushing the plunger to the barrel flange, a piece of the barrel flange broke and a shard of glass broke through the administering Nurse's glove and cut her finger.           o Does the syringe have a broken component? YES (e.g. broken syringe tip; loose or detached luer lock, or broken finger flange)                 o If yes, describe in detail how it is broken. Nurse reporting product quality complaint pertaining to hepatitis a vaccine, inactivated (VAQTA) along with adverse event. Nurse reports that another Nurse was administering hepatitis a vaccine, inactivated (VAQTA) to a patient and while pushing the plunger to the barrel flange, a piece of the barrel flange broke and a shard of glass broke through the administering Nurse's glove and cut her finger. Nurse reports that patient was not injured during the administration of hepatitis a vaccine, inactivated (VAQTA).                  o Provide the exact location of the breakage on the syringe?                 o Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? NO         o Was there difficulty trying to attach the syringe needle to the syringe? NO                    o If yes, describe                    o If yes, was it supplied by MERCK: YES/NO/NA/UNSPECIFIED                    o If not supplied by MERCK, what type & brand, needle size and gauge was used?'  o Under what situation was this defect noticed: (select one)         o While the syringe was still in the tray? NO                 o If yes, is there product (liquid or dried residue) in the tray? YES/NO/NA/UNSPECIFIED                 o Is there any broken glass or other separated component in the tray? (if yes specify)          o After removing the syringe from the tray? NO          o While trying to attach the needle to the syringe? NO           o While giving the injection? YES           o Immediately after giving the injection? YES  o Was the syringe tip cap attached properly prior to use? YES          o If no, describe issue:  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. UNSPECIFIED         o If no, describe damage  o Was the syringe carton damaged prior to use? (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)? YES  o If complaint sample is not/cannot be returned, please provide reason: Nurse reports that syringe has been disposed of.  *If photos are available, ask the customer to send them to email  Retrieval Information:  o Obtain product (and tray if possible) o 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: Unknown Insertion Difficulty: Not Applicable Insertion Difficulty Details: Not Applicable Doubt About Presence: Not Applicable Doubt Details: Not Applicable Migration: Not Applicable Migration Details: Not Applicable Removal Problem: Not Applicable Removal Problem Details: Not Applicable  16-MAR-2022 18:30 PM: Agent placed outbound call to inquire if syringe can be obtained. Nurse stated that syringe has been dispose of. No further details provided.  16-MAR-2022 18:30 PM: Attachment added.  17-MAR-2022: Based on the review of the PQC the priority for this record has been changed per Product Quality Complaint, Complaint Category and Risk Priority Table.  17-MAR-2022: Second person reviewed ; Sender's Comments:  US-009507513-2203USA007024: