Sex: U
Vaccine: PNC15
Symptoms: Syringe issue
Clinical narrative: no adverse event; the syringe barrel shattered/Broken Syringe Barrel; after administering the product to a patient; Complaint Description Summary After administering the product to a patient while placing the safety cap on the product the syringe barrel shattered.  Complaint Description Detail HCP calling to report PQC for pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE). HCP stated on 11-JUL-2023, after administering the product to a patient while placing the safety cap on the product the syringe barrel shattered. No one was hurt or injured as per HCP. Product cannot be retrieved because it was already disposed of. Pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) Lot #W039033, expiration date 01-OCT-2024. HCP could not provide the NDC because the box was thrown out. HCP confirmed it came in box of 10, obtained NDC from PI. Replacement request case#02432332. No AE reported. No additional PQC reported. 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.) while flipping the Safety cap on, when that back came on the top of the syringe , the glass part broke off and shattered. Provide the exact location of the breakage on the syringe? the whole syringe Does the syringe have a broken component? NO, needle stayed intact If yes, describe in detail how it is broken. Provide the exact location of the breakage on the syringe? the glass barrel broke Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? NO Was anyone injured as a result of the breakage? NO If yes, provide brief description of injury Note: Report an AE if yes as outlined in Instruction section Was there difficulty trying to attach the syringe needle to the syringe NO If yes, describe If yes, was it supplied by MERCK: YES/NO/NA/UNSPECIFIED If not supplied by MERCK, what type & brand, needle size & gauge was used? Under what situation was this defect noticed: (select one) While the syringe was still in the tray? NO If yes, is there product (liquid or dried residue) in the tray? YES/NO/NA/UNSPECIFIED Is there any broken glass or other separated component in the tray? (if yes specify) After removing the syringe from the tray? NO While trying to attach the needle to the syringe? NO While giving the injection? NO Immediately after giving the injection? YES, while putting the safety cap on. Was the syringe tip cap attached properly prior to use? YES If no, describe issue: Was the syringe tray intact and undamaged on receipt? YES If no, describe damage. If the product came with a cellophane cover, was the cellophane covering the syringe tray intact and completely sealed? 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)? YES, given to patient If complaint sample is not/cannot be returned, please provide reason: Not able to sent sample back, in too many pieces and they disposed the product If photos are available, ask the customer to send them to email, no pictures to provide already disposed  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: 21-JUL-2023 Reviewer 1: The complaint description states, "after administering the product to a patient while placing the safety cap on the product the syringe barrel shattered" and PQC intake questions are answered as below: Is the syringe broken into 2 or more pieces? YES If yes, describe in detail how it is broken - while flipping the Safety cap on, when that back came on the top of the syringe , the glass part broke off and shattered. Under what situation was this defect noticed: Immediately after giving the injection? YES, while putting the safety cap on. - As per the complaint description and the answers to the PQC intake questions, the record is being categorized under, Broken Syringe - Broken During or After Injection. DPOC will be notified to provide complaint sample pictures. 21-JUL-2023: Reviewer 2: Second person review completed. 21-JUL-2023 at 15:31: Attachment added. 21-JUL-2023 at 15:31: Email received on 21-JUL-2023 at 1426 from DPOC stating in verbatim "Please reach out to the reporter and request for complaint sample pictures if available." See attached. Case will be forwarded to agent for follow up. No additional information. 21-JUL-2023 at 15:31 :Outbound call made to HCP to see if HCP can provide pictures. HCP had stated earlier there is no product retrieval due to pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) being disposed. When HCP calls back please confirm if there are any pictures they can provide. 21-JUL-2023 at 15:31: Reporter called back. No picture to send. It was thrown out before she received the message.