Sex: U
Vaccine: HEP
Symptoms: Syringe issue
Clinical narrative: no adverse event; Sterile Injectable;N/A;Broken Syringe; Complaint Description Detail  Nurse calling to report they received a box of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) pre-filled syringes and one of the pre-filled syringes had a broken finger flange. This was noticed upon opening the box so product was not used or given to any  patients. See case for replacement request. Product was available for retrieval. No additional PQC. No AE.  QUESTION SECTION:   Medium Risk: Broken Syringe Barrel High Risk: Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange.  Notes for Agency:  o A cracked syringe had a line or chip in the glass, but the syringe was essentially intact in one piece. A syringe was considered broken when the syringe was in 2 or more pieces. o A syringe was also considered "cracked" if it appeared to be intact with evidence of a chip or crack or appeared to be intact initially but then broke 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 Was there a crack? NO. THERE WAS AN ENTIRE PEICE OF GLASS BROKEN OFF INTO THE TRAY FROM THE FINGER FLANGE                 o If yes, describe the size, shape & depth of the crack: N/A                 o Provide the exact location of the crack on the syringe: N/A         o Was the syringe broken into 2 or more pieces? YES                 o If yes, describe in detail how it was broken: (e.g. shattered, broken in half etc.) A SINGLE PEICE OF THE FINGER FLANGE WAS BROKEN OFF                 o Provide the exact location of the breakage on the syringe? FINGER FLANGE          o Did the syringe have a broken component? YES/NO/NA/UNSPECIFIED (e.g. broken syringe tip; loose or detached luer lock, or broken finger flange) YES. FINGER FLANGE                 o If yes, describe in detail how it was broken. A SINGLE PEICE OF THE FINGER FLANGE WAS BROKEN OFF                 o Provide the exact location of the breakage on the syringe? FINGER FLANGE                 o Was the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? NO          o Was there difficulty trying to attach the syringe needle to the syringe? NO. A NEEDLE WAS NEVER ATTEMPTED TO BE ATTACHED                    o If yes, describe N/A                    o If yes, was it supplied by manufacturing site N/A                    o If not supplied by manufacturing site, what type & brand, needle size & gauge was used?' N/A  o Under what situation was this defect noticed: (select one)         o While the syringe was still in the tray? YES                 o If yes, was there product (liquid or dried residue) in the tray? NO                 o Was there any broken glass or other separated component in the tray? (if yes specify) YES. PART OF FINGER FLANGE WAS BROKEN OFF INTO TRAY          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? NO           o Immediately after giving the injection? NO  o Was the syringe tip cap attached properly prior to use? THIS PRODUCT WAS NOT USED OR ATTEMPTED TO BE USED          o If no, describe issue: N/A  o Was the syringe tray intact and undamaged on receipt? YES         o If no, describe damage. N/A  o If the product came with a cellophane cover, was the cellophane covering the syringe tray intact and completely sealed?  *See below. YES. NOT DAMAGED         o If no, describe damage N/A  o Was the syringe carton damaged prior to use?  (i.e. crushed, ripped, unglued) NO          o If yes, describe N/A  o Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? NO  o If complaint sample was not/cannot be returned, please provide reason.  08-JUL-2022 14:30 PM: Attachment added to System.  08-JUL-2022: Second person review.  08-JUL-2022 15:30 PM: Waiting for Retrieval Site from Quality--See attachments  08-JUL-2022 15:30 PM: Attachment added to System.  08-JUL-2022 15:30 PM: Attachment added to System.  08-JUL-2022 15:30 PM: Emails receive in the Contact Center mailbox on 8Jul2022 at 2:45 pm with request for retrieval site, then an email requesting that the first email be disregarded. See attachment.  08-JUL-2022 15:30 PM: Attachment added to system.  08-JUL-2022 17:30 PM: Labels created for manufacturing site 08-JUL-2022