Sex: U
Vaccine: HEPA
Symptoms: Syringe issue
Clinical narrative: the bottom of the glass portion of the syringe had broken off; no harm to a patient/ no additional AR reported; the bottom of the glass portion of the syringe had broken off; Complain Description Detail:  Employee submitting an AE/PQC for Hepatitis A Vaccine, Inactivated (VAQTA) on behalf of a medical assistant. Caller emailed a statement submitted by the medical assistant who was injured during administering Hepatitis A Vaccine, Inactivated (VAQTA) to a patient; "I was administering the Hep A vaccine to a patient, and I did not notice anything wrong with the pre-filled syringe as I was drawing up the vaccine. As I was injection the vaccine, the bottom of the glass portion of the syringe had broken off and caused me to cut my middle finger during administration. There was no harm to the patient and all glass had been contained in my hand. I cannot list the LOT number of the vaccine as this occurrence happened a few months ago and I am unable to find records of it". No additional information reported. No additional AE/PQC reported. See also AE case 02170093. 21-MAY-2022 24:07: Email received in the mailbox on 20-MAY-2022 at 17:16 with pictures associated with this case. See attachment. 21-MAY-2022 24:07: 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 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.  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). 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 2 pieces Provide the exact location of the breakage on the syringe? finger flange Does the syringe have a broken component? YES (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? UNSPECIFIED (if yes describe) Was there difficulty trying to attach the syringe needle to the syringe? UNSPECIFIED 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?' UNSPECIFIED Under what situation was this defect noticed: (select one) While the syringe was still in the tray? NO If yes, is there product (liquid or dried residue) in the tray? YES/NO/NA/UNSPECIFIED 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? YES Immediately after giving the injection? NO Was the syringe tip cap attached properly prior to use? UNSPECIFIED If no, describe issue: Was the syringe tray intact and undamaged on receipt? UNSPECIFIED 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. UNSPECIFIED If no, describe damage Was the syringe carton damaged prior to use? (i.e. crushed, ripped, unglued) UNSPECIFIED If yes, describe Was the product administered or exposed to patient' s bodily fluids (i.e. biohazardous)? YES If complaint sample is not/cannot be returned, please provide reason: discarded after use 21-MAY-2022 24:07: Attachment added to Service. 23-MAY-2022; Second person reviewed by Company employee 1 Complaint Description Summary  Caller is reporting a broken syringe while administering it to the patient.  This is one of 2 reports received from the same reporter. ; Sender's Comments:  US-009507513-2205USA006761: