Sex: U
Vaccine: HEP
Symptoms: No adverse event, Syringe issue
Clinical narrative: no adverse event; the flange on the plunger was broken off of 1 of the RECOMBIVAX HB prefilled syringes; small dent on the outside of the box; Customer called and reported that they received a direct order shipment of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) yesterday 13-JUN-2022. Today, 14-JUN-2022 the customer opened the box and noticed that the flange on the plunger was broken off of 1 of the hepatitis b vaccine (recombinant) (RECOMBIVAX HB) prefilled syringes. She reports that there was a small dent on the outside of the box. The product was not administered to a consumer. No AE reported. No additional PQC reported. No additional information provided. QUESTION SECTION:   Medium Risk:  Broken Syringe Barrel High Risk:  Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange.  Notes for agency:   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          Is the syringe broken into 2 or more pieces? NA          Does the syringe have a broken component? YES (e.g. broken syringe tip; loose or detached luer lock, or broken finger flange) BROKEN FLANGE                   If yes, describe in detail how it is broken. THE FLANGE IS BROKEN OFF                  Provide the exact location of the breakage on the syringe? AT THE BOTTOM OF THE FLANGE                   Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? NO           Was there difficulty trying to attach the syringe needle to the syringe? NA - NO NEEDLE ATTACHED   Under what situation was this defect noticed: (select one)          While the syringe was still in the tray? YES                  If yes, is there product (liquid or dried residue) in the tray? NO                  Is there any broken glass or other separated component in the tray? (if yes specify) YES, THE BROKEN PIECE IS SEPARATE FROM THE SYRINGE           After removing the syringe from the tray? NO           While trying to attach the needle to the syringe? NO           While giving the injection? NO           Immediately after giving the injection? NO   Was the syringe tip cap attached properly prior to use? NA = PRODUCT NOT USED   Was the syringe tray intact and undamaged on receipt? YES   If the product came with a cellophane cover, was the cellophane covering the syringe tray intact and completely sealed?  See below.          If no, describe damage  NO, DID NOT COME WITH A CELLOPHANE COVER   Was the syringe carton damaged prior to use?  (i.e. crushed, ripped, unglued)            If yes, describe THE CARTON HAD A SMALL DENT ON IT.    Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? NO   If complaint sample is not/cannot be returned, please provide reason:   If photos are available, ask the customer to send them to mailbox.  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:  14-JUN-2022 18:30 PM :Attachment added to System.  14-JUN-2022 18:30 PM :Attachment added to System.  14-JUN-2022 18:30 PM :Email received in the mailbox on 14-JUN-2022 at 17:20 with photos for this case. See attached.  15-JUN-2022 Received & Attached Photos. 15-JUN-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. 15-JUN-2022 Second person reviewed.   15-JUN-2022 14:31 PM :Waiting for Quality-- See attachments  15-JUN-2022 14:31 PM :Attachment added to System.  15-JUN-2022 17:30 PM :Attachment added to System.  Complaint Description Summary Caller is reporting that she noticed that the flange on the plunger was broken off of 1 of the hepatitis b vaccine (recombinant) (RECOMBIVAX HB) prefilled syringes and that there was a small dent on the outside of the box.