Sex: U
Vaccine: HEP
Symptoms: Injury, Pain in extremity, Syringe issue, Wound
Clinical narrative: The patient received the full dose of vaccine; a piece of the finger flange broke off during the injection of a patient; No additional AEs reported; Complaint Description Detail  Heath Care Professional (HCP) reports a PFS of hepatitis B Vaccine (Recombinant)(RECOMBIVAX HB) broke and punctured a medical assistant's thumb.  HCP states the medical assistant noticed pain in her thumb while administering the vaccination and realized a piece of the finger flange broke off during the injection of a patient.  The patient received the full dose of vaccine.  The medical assistant did require medical care for injury.  No other information provided.  No additional AEs or PQCs reported.  Caller will send pictures of PFS and hold for return.  not sent as HCP information for AE is not known. 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.) PIECE OF GLASS IS BROKEN OFF OF THE FINGER FLANGE 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) FINGER FLANGE If yes, describe in detail how it is broken. PIECE OF GLASS BROKE OFF THE FLANGE 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? NO 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?"  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? YES If no, describe issue:  Was the syringe tray intact and undamaged on receipt? YES 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. YES If no, describe damage  Was the syringe carton damaged prior to use?  (i.e. crushed, ripped, unglued) NO 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:   *If photos are available, ask the customer to send them  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. 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:  18-NOV-2022 14:30 PM :Attachment added. 21-NOV-2022: Attached email with photo received from DPOC. 21-NOV-2022: Second person review completed. 21-NOV-2022 15:30 PM :Attachment added. 21-NOV-2022 15:30 PM :Waiting on retrieval site from Quality ; Sender's Comments:  US-009507513-2211USA007287: