Sex: F
Vaccine: HEPA
Symptoms: Injury associated with device, Skin laceration, Syringe issue, Wound
Clinical narrative: the nurse was giving the vaccination when the ring where plunger pushes through broke and cut the nurse; the nurse was giving the vaccination when the ring where plunger pushes through broke and cut the nurse; the nurse was giving the vaccination when the ring where plunger pushes through broke and cut the nurse; This spontaneous report has been received from a nurse concerning a female patient of an unknown age. Patient's medical history, current conditions, concomitant medications and previous drugs allergies or reactions were not reported. On an unknown date the nurse was vaccinated a patient with hepatitis a vaccine, inactivated (VAQTA) lot#W029899 expiration date 16-MAY-2024 at a dose on 0.5 milliliter as prophylaxis and the ring where plunger pushes through broke and cut the nurse (Injury associated with device, Skin laceration).   Complaint Description Detail Merck representative reporting an AE/PQC for hepatitis a vaccine, inactivated (VAQTA). Caller stated the nurse was giving the vaccination when the ring where plunger pushes through broke and cut the nurse. Per caller, the patient received the full dose, and there was no AE for the patient. Caller stated the office did send a picture of the syringe that she would email for this case. Caller had no further information. Customer was not on call. No additional AE/PQC. Attachment added to Service Cloud. Sample Tracking Number: User's Experience: Unknown Insertion Difficulty: Insertion Difficulty Details: Doubt About Presence: Doubt Details: Migration: Migration Details: Removal Problem: Removal Problem Details: 02-MAR-2023 17:30 PM :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: NA  Provide the exact location of the crack on the syringe: NA 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.) FINGER FLANGE BROKE OFF. SEE ATTACHED PICTURE  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. FINGER FLANGE BROKE OFF THE SYRINGE  Provide the exact location of the breakage on the syringe? FINGER FLANGE  Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? NO (if yes describe)  Was there difficulty trying to attach the syringe needle to the syringe? UNSPECIFIED  If yes, describe NA  If yes, was it supplied by MERCK: UNSPECIFIED  If not supplied by MERCK, what type & brand, needle size & gauge was used?' NA  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? NA  Is there any broken glass or other separated component in the tray? (if yes specify) NA  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: NA  Was the syringe tray intact and undamaged on receipt? UNSPECIFIED  If no, describe damage. NA  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 NA  Was the syringe carton damaged prior to use? (i.e. crushed, ripped, unglued) UNSPECIFIED  If yes, describe NA  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: unspecified. agent has not spoken with customer. it is unclear if sample is available to retrieve. If photos are available, ask the customer to send them to  Retrieval Information:  Obtain product (& tray if possible)  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. 02-MAR-2023 17:30 PM :Outbound call placed to customer. Message left with case number, contact number and hours of contact. Agent filing AE/PQC with information received from Merck representative. If agent is unavailable when call is received, please collect demographics for customer as representative did not have last name of customer. Also, please gather answers, determine if mailer can be sent, any additional information customer has for AE, and gather information to open CR case. Thank you! 03-MAR-2023: DPOC email containing photo was attached. 03-MAR-2023: Second person review completed  Complaint Description Summary The finger flange broke off when nurse was giving the vaccination.