Sex: U
Vaccine: PNC15
Symptoms: Needle issue, Syringe issue
Clinical narrative: No adverse event; Broken Syringe; Complaint Description Detail Customer calling to report that one of the syringes in a tray of VAXNEUVANCE had a broken finger flange that separated from the syringe itself. Customer confirms no patient involvement and confirms the rest of the VAXNEUVANCE syringes in the trays are intact and do not have any issue. Customer confirms it was just one syringe in the one tray that had a finger flange that separated from the barrel. Customer states she will be sending images of the product via email. Customer states that the product is available for retrieval. No additional PQC. No AE reported.   VAXNEUVANCE LOT number from the VAXNEUVANCE product itself: W021510 exp. 08-OCT-2023 NDC number on VAXNEUVANCE product itself: 0006432901  LOT number on VAXNEUVANCE CARTON: W021510 exp. 08-OCT-2023 NDC number on CARTON of ten VAXNEUVANCE: 0006432903 QUESTION SECTION: Medium Risk: Broken Syringe Barrel High Risk: Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange.   Notes for DPOC:  o 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. PRODUCE IS BROKEN o 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). NA  o Please provide a detailed description of the defect using the questions below:        o Is there a crack? There is no crack, the product is in two pieces. The finger flange separated from the barrel of the product.                 o If yes, describe the size, shape & depth of the crack: NA                 o Provide the exact location of the crack on the syringe: NA         o Is the syringe broken into 2 or more pieces? YES                 o If yes, describe in detail how it is broken: (e.g. shattered, broken in half etc.) The finger flange is separated from the barrel. the piece where your fingers go, is separated from the barrel of the syringe.                  o Provide the exact location of the breakage on the syringe? The finger flange is separated from the barrel.           o Does the syringe have a broken component? The finger flange is separated from the barrel.                  o If yes, describe in detail how it is broken. The finger flange is separated from the barrel                 o Provide the exact location of the breakage on the syringe? The finger flange is separated from the barrel                 o Is 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. It was found in the package this way.                     o If yes, describe NA                    o If yes, was it supplied by MERCK: NA                    o If not supplied by MERCK NA  o Under what situation was this defect noticed: (select one)         o While the syringe was still in the tray? YES                  o If yes, is there product (liquid or dried residue) in the tray? No the product is still contained in the syringe.                 o Is there any broken glass or other separated component in the tray? NO          o After removing the syringe from the tray? NA          o While trying to attach the needle to the syringe? NA           o While giving the injection? NA           o Immediately after giving the injection? NA  o Was the syringe tip cap attached properly prior to use? NA  o Was the syringe tray intact and undamaged on receipt? YES  o If the product came with a cellophane cover, was the cellophane covering the syringe tray intact and completely sealed? YES         o If no, describe damage NA  o Was the syringe carton damaged prior to use? (i.e. crushed, ripped, unglued) NO  o Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? NO  o If complaint sample is not/cannot be returned, please provide reason: PRODUCT CAN BE RETURNED  *If photos are available, ask the customer to send them: PHOTOS WILL BE EMAILED. CASE NUMBER PROVIDED  Retrieval Information:  o Obtain product (& tray if possible) TRAY IS AVAILABLE o 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:  10-NOV-2022 20:30 PM :Attachment added.  11-NOV-2022 Anonymized: As the complaint photographs are not available, PQC category is selected based on nature of complaint mentioned in complaint description detail. Once the photographs received from DPOC / complainant, record will be updated if required. Complaint sample record # 374877 has been created as the complaint sample available for return. Record processed for second person review.  11-NOV-2022: Second person review performed by Anonymized.  11-NOV-2022 16:30 PM :Attachment added.  11-NOV-2022 16:30 PM :Labels created 11-NOV-2022