Sex: F
Vaccine: HEPA
Symptoms: Syringe issue
Clinical narrative: the nurse in which she suffered a laceration; the finger flange syringe base broke into multiple pieces; Caller reported that yesterday another nurse was administering a pediatric pre-filled syringe dose of hepatitis a vaccine, inactivated (VAQTA) pre-filled syringe to unknown patient. Caller reported that while the nurse was injecting the dose, the finger flange syringe base broke into multiple pieces. Caller reported that this resulted in an injury to the nurse in which she suffered a laceration, which required 2-Octyl cyanoacrylate (DERMABOND) to seal the wound. Caller did not specify specific area of the nurse's injury (ie hand vs finger), agent therefore filled full adverse event with limited information. Caller reported that the patient received their dose and there was no injury to patient at all. Agent therefore also filed misuse adverse event for unknown patient that received defective dose, please reference AE case 02173265. Caller provided the other nurse's initials (that suffered injury), which was placed in the patient name fields. Caller would attempt to provide pictures of syringe and stated that syringe was available for retrieval but it had been exposed to nurse's bodily fluids, therefore marked hazardous. No further information provided. No other adverse events or product quality complaints reported. QUESTION SECTION: Medium Risk: Broken Syringe Barrel High Risk: Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange. Notes for DPOC: 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: NA o Provide the exact location of the crack on the syringe: NA o Is the syringe broken into 2 or more pieces? NO o If yes, describe in detail how it is broken: (e.g. shattered, broken in half etc.) NA o Provide the exact location of the breakage on the syringe? NA 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. BROKEN FINGER FLANGE, BROKE INTO TWO OR MORE PIECES WHILE USING o Provide the exact location of the breakage on the syringe? FINGER FLANGE, SYRINGE BASE o Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? NO (if yes describe) o Was there difficulty trying to attach the syringe needle to the syringe? NO 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 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? NA o Is there any broken glass or other separated component in the tray? (if yes specify) NA 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, BROKE WHILE GIVING INJECTION o Immediately after giving the injection? NA o Was the syringe tip cap attached properly prior to use? YES o If no, describe issue: NA o Was the syringe tray intact and undamaged on receipt? YES o If no, describe damage. NA 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 NA o Was the syringe carton damaged prior to use? (i.e. crushed, ripped, unglued) NO o If yes, describe NA o Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? YES, ADMINISTERED TO UNKNOWN PATIENT AND EXPOSED TO HEALTHCARE PROFESSIONAL'S BODY FLUIDS o If complaint sample is not/cannot be returned, please provide reason: SAMPLE AVAILABLE FOR RETURN *If photos are available, ask the customer to send them to email address Retrieval Information: o Obtain product (& 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: Repeat User Insertion Difficulty: Insertion Difficulty Details: Doubt About Presence: Doubt Details: Migration: Migration Details: Removal Problem: Removal Problem Details: 25-MAY-2022 17:30 PM :Attachment added. 25-MAY-2022 17:30 PM :Attachment added. 25-MAY-2022 17:30 PM :Waiting for Retrieval Site from Quality-- See attachments 25-MAY-2022 17:30 PM :Attachment added. 26-MAY-2022; Second person reviewed 26-MAY-2022 10:30 AM :Attachment added. 26-MAY-2022 10:30 AM :Email received in the Mailbox on 25-MAY-2022 at 6:35pm with pictures related to this case. See attached. 26-MAY-2022 11:30 AM :Attachment added. 26-MAY-2022 11:30 AM :Labels created 05/26/2022 Tracking OUTBOUND:  Tracking RETURN:  26-MAY-2022: Received & attached photos. 26-MAY-2022 17:30 PM :Agent attempted an outbound call to the customer. Agent spoke with colleague who placed the agent on hold to bring customer on the line. After an extended hold period someone from office picked up the line and subsequently disconnected. Agent was attempting to inform the customer that quality will be retrieving the product and a mailer is being sent to her. NEXT AGENT if customer calls back referencing this case, please make aware of above. Thank you. Caller reports that while the nurse was injecting the dose, the finger flange syringe base broke into multiple pieces.