Sex: U
Vaccine: PNC15
Symptoms: Syringe issue
Clinical narrative: No additional AE/additional PQC; the finger flange fully broke off from the syringe/broken syringe/broken during or after injection; the finger flange fully broke off from the syringe/broken syringe/broken during or after injection; Complaint Description Detail Agency called to report PQC for pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE). HCP reported details over the phone as agency was on site. HCP stated that while pushing down on the plunger rod the finger flange fully broke off from the syringe. No injury was reported. Pictures are available to send but the product was disposed of and is not able to be obtained. Call ended prior to asking AE questions. HCP permission to contact obtained. No additional AE/additional PQC. QUESTION SECTION: Medium Risk: Broken Syringe Barrel High Risk: Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange. Notes: 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 is in 2 or more pieces. o A syringe was 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). o Please provide a detailed description of the defect using the questions below: o Is there a crack? YES o If yes, describe the size, shape & depth of the crack: CIRCLULAR CRACK AROUND FINGER FLANGE o Provide the exact location of the crack on the syringe: FINGER FLANGE BROKE IN A CIRCLE ALL THE WAY AROUND AND DETACHED FROM SYRINGE 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.) FINGER FLANGE BROKE IN A CIRCLE ALL THE WAY AROUND AND DETACHED FROM SYRINGE o Provide the exact location of the breakage on the syringe? FINGER FLANGE BROKE IN A CIRCLE ALL THE WAY AROUND AND DETACHED FROM SYRINGE Does the syringe have a broken component? YES (e.g. broken syringe tip; loose or detached luer lock, or broken finger flange) BROKEN FINGER FLANGE o If yes, describe in detail how it is broken. FINGER FLANGE BROKE IN A CIRCLE ALL THE WAY AROUND AND DETACHED FROM SYRINGE o 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) o Was anyone injured as a result of the breakage? NO o If yes, provide brief description of injury NA o Note: Report an AE if yes as outlined in Instruction section o Was there difficulty trying to attach the syringe needle to the syringe? NO o If yes, describe NA o If yes, was it supplied by MERCK: NA o If not supplied by MERCK, what type & brand, needle size & gauge was used?' NA Under what situation was this defect noticed: (select one) o While the syringe was still in the tray? NO o If yes, is there product (liquid or dried residue) in the tray? NA o Is there any broken glass or other separated component in the tray? (if yes specify) NA 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? YES - NEEDLE WAS IN PATIENT AS I TRIED TO ADMINSITER PRODUCT, THE FINGER FLANGE BROKE OFF AND STAYED AROUND THE PLUNGER ROD, BUT WAS CRACKED ALL THE WAY AROUND AND DETACHED FROM THE SYRINGE o Immediately after giving the injection? NO o Was the syringe tip cap attached properly prior to use? YES o If no, describe issue: NA Was the syringe tray intact and undamaged on receipt? YES o If no, describe damage. NA o If the product came with a cellophane cover, was the cellophane covering the syringe tray intact and completely sealed? *See below. YES o If no, describe damage NA o Was the syringe carton damaged prior to use? (i.e. crushed, ripped, unglued) NO o If yes, describe NA o Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? YES o If complaint sample is not/cannot be returned, please provide reason: HCP DISPOSED OF PRODUCT *If photos are available, ask the customer to send them Retrieval Information: o Obtain product (& tray if possible) NOT 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: 27-JUL-2023 12:30 PM: Attachment added. 27-JUL-2023: - Based on the reported information that the finger flange broke while pushing the plunger rod, the PQC category "Broken Syringe (Broken During or After injection)" has been selected. 27-JUL-2023:: Second person review completed. Complaint Description Summary HCP stated that while pushing down on the plunger rod the finger flange fully broke off from the syringe