Sex: U
Vaccine: PNC15
Symptoms: Syringe issue
Clinical narrative: No additional AEs or PQC reported; Broken syringe/broken during or after injection; Broken syringe/broken during or after injection; Complaint Description Detail Inbound call reporting PQC for HCP. Agency had no details of PQC except product name. Outbound call to HCP and information obtained for PQC and AE. HCP states finger flange of PFS of pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE) broke during injection. No other information provided. No additional AEs or PQC reported. Operator of PFS was HCP. 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 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 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? NO o If yes, describe the size, shape & depth of the crack: o Provide the exact location of the crack on the syringe: 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.) FLINGER FLANGE IS BROKEN OFF AND BROKEN INTO 3 PIECES o Provide the exact location of the breakage on the syringe? FINGER FLANGE o Does the syringe have a broken component? YES (e.g. broken syringe tip; loose or detached luer lock, or broken finger flange) o If yes, describe in detail how it is broken. FINGER FLANGE WAS BROKEN OFF o Provide the exact location of the breakage on the syringe? FLINGER FLANGE o Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? NO (if yes describe) Was anyone injured as a result of the breakage? NO o If yes, provide brief description of injury 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 o If yes, was it supplied by MERCK: NA o If not supplied by MERCK, what type & brand, needle size & gauge was used?' o 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 After removing the syringe from the tray? NA o While trying to attach the needle to the syringe? NO o While giving the injection? YES o Immediately after giving the injection? NO o Was the syringe tip cap attached properly prior to use? YES o If no, describe issue: o Was the syringe tray intact and undamaged on receipt? YES o If no, describe damage. 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 Was the syringe carton damaged prior to use? (i.e. crushed, ripped, unglued) NO o If yes, describe 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 will hold product for return *If photos are available, ask the customer to send them. HCP will sent photos to email. Retrieval Information: o Obtain product (& tray if possible) 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: Not Applicable Insertion Difficulty Details: Not Applicable Doubt About Presence: Not Applicable Doubt Details: Not Applicable Migration: Not Applicable Migration Details: Not Applicable Removal Problem: Not Applicable Removal Problem Details: Not Applicable 27-JUL-2023 16:30 PM : Attachment added. 27-JUL-2023 16:30 PM : Attachment added. 27-JUL-2023 16:30 PM : Attachment added. 27-JUL-2023 16:30 PM : Awaiting retrieval site -- See Attachment 27-JUL-2023 16:30 PM : Attachment added. 27-JUL-2023 17:30 PM : Attachment added. 27-JUL-2023 17:30 PM : Email received in Contact Center inbox on 27-JUL-2023 containing photos of pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE). See attached. No additional information. 28-JUL-2023: As per narrative HCP states finger flange of PFS of pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE) broke during injection' hence the report was being categorized as 'Broken Syringe > Broken During or After injection (Primary Packaging)'. - Product ID selected as '1047050'. - Field is marked as, 'Yes'. - Occurrence has been selected as '1'. - The priority of the report is selected as 'High'. - Device reportability updated accordingly. - Since finger flange is broken secondary packaging site has been selected. - HCP will sent photos to email'. - AE-PQC letter, pictures, Biohazard letter, Request form received on 28-JUL-2023 and same has been attached to report. - As per picture defect is confirmed. 28-JUL-2023: Second person review completed 28-JUL-2023 08:30 AM : Attachment added. 28-JUL-2023 08:30 AM : Retrieval site. 28-JUL-2023 09:30 AM : Labels created. o Shipped on 28-JUL-2023  28-JUL-2023 10:30 AM : Attachment added. 28-JUL-2023 10:30 AM : Email received in the PQC Mailbox on 28-JUL-2023 at 6:54AM with the following message from Quality, "Acknowledged receipt of the PQC." See attached.