Sex: U
Vaccine: PNC15
Symptoms: Syringe issue
Clinical narrative: no adverse event; Sterile Injectable;N/A;Broken Syringe; Office manager reports at least 2 broken finger flanges on pre-filled syringes of VAXENUVANCE. Office manager states medical assistant heard something in the unopened box moving around and opened the box to discover at least 2 broken finger flanges with glass pieces in the box. Product is available for retrieval.  See CR request case 02227250 for replacement. No AE reported. No additional PQC.  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.) FINGER FLANGE IS BROKEN Provide the exact location of the breakage on the syringe?  FINGER FLANGE  Does 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. BROKEN FINGER FLANGE If yes, describe in detail how it is broken. FINGER FLANGE IS BROKEN OFF 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? YES/NO/NA/UNSPECIFIED (if yes describe) NO  Was there difficulty trying to attach the syringe needle to the syringe? NO. THIS WAS NOT ATTEMPTED  If yes, describe N/A If yes, was it supplied by MERCK: N/A If not supplied by MERCK, what type & brand, needle size & gauge was used? N/A  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? UNKNOWN Is there any broken glass or other separated component in the tray? (if yes specify) YES. PART OF THE BROKEN FINGER FLANGE IS IN THE TRAY. IT WAS NOTICED BECAUSE MEDICAL ASSISTANT HEARD SOMETHING MOVING AROUND LOOSE IN THE TRAY AND OPENED IT TO FIND GLASS PEICES  After removing the syringe from the tray? NO. THIS WAS NOTICED WHILE THE SYRINGES WERE IN THE TRAY. BECAUSE THEY WERE BROKEN, NO SYTRINGES WERE REMOVED FROM THE TRAY  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? N/A If no, describe issue:  Was the syringe tray intact and undamaged on receipt? YES If no, describe damage. N/A  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)? NO  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:  16-Aug-2022 19:30: Attachment added.  17Aug2022: Second person review performed by Company employee 1  17-Aug-2022 12:30: Waiting for Retrieval Site from Quality--See attachments  17-Aug-2022 12:30: Attachment added.  17-Aug-2022 13:30: Attachment added.  17-Aug-2022 13:30: Labels created 08/17/2022    17-Aug-2022 13:30:******CORRECTION TO N-793646*******