Sex: U
Vaccine: PNC15
Symptoms: Syringe issue
Clinical narrative: FBE has no additional AE/PQC details.; FBE called to report a AE/PQC on behalf of an HCP. FBE reports that when an RN in the practice went to dispose of a single syringe of VAXNEUVANCE, the PFS broke. FBE reports that the dose was fully administered to the patient, and no injuries were re; FBE called to report a AE/PQC on behalf of an HCP. FBE reports that when an RN in the practice went to dispose of a single syringe of VAXNEUVANCE, the PFS broke. FBE reports that the dose was fully administered to the patient, and no injuries were re; This spontaneous report has been received from a nurse via company representative, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies were not reported.   On 27-FEB-2024, the patient was vaccinated with a dose of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) pre-filled syringe, at a dose of 0.5 milliliter as prophylaxis (frequency reported as once) (lot number: X019438, which was determined to be valid by the validation lot team, with an expiration date on: 07-NOV-2025) (scheme, route and anatomical location of administration were not reported).  On this same date, when a registered nurse (RN) in the practice went to dispose of a syringe of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE), she was attempting to place a safety cap back on the device when the needle and the hub broke completely off the pre-filled syringe (PFS) (syringe issue). The dose was fully administered to the patient (poor quality device used), and no injuries resulted of the breakage were reported by the health care professional (HCP). The HCP reported the product was not available for retrieval and no photos were taken prior to disposal. No additional adverse event (AE) details (no adverse event).   QUESTION SECTION: Medium Risk: Broken Syringe Barrel High Risk: Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange.  Notes for Designated Point of Contact (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. 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.) HCP reports that a cap was being placed onto the used device and when the HCP exerted pressure onto the syringe to connect the cap, the hub broke off the PFS. HCP reports the needle and hub broke off the barrel completely. Provide the exact location of the breakage on the syringe? Hub of the syringe.  Does the syringe have a broken component? Yes (e.g. broken syringe tip; loose or detached luer lock, or broken finger flange, finger flange back-stop)  If yes, describe in detail how it is broken. HCP reports that a cap was being placed onto the used device and when the hcp exerted pressure onto the syringe to connect the cap, the hub broke off the PFS. HCP reports the needle and hub broke off the barrel completely.  Provide the exact location of the breakage on the syringe? Hub.  Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? Yes (if yes describe in detail) HCP reports that a cap was being placed onto the used device and when the hcp exerted pressure onto the syringe to connect the cap, the hub broke off the PFS. HCP reports the needle and hub broke off the barrel completely.  Is there difficulty attaching the Syringe Needle to the Syringe? No. Was the syringe needle attached or being attached to the syringe tip when the issue or breakage was noted or occurred? No. Was anyone injured as a result of the breakage? No. Note to CSR: Report an AE if yes as outlined in Instruction section.  Under what situation was this defect noticed: (select one) While the syringe was still in the tray? No.  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. Was the syringe tip cap attached properly prior to use? Yes. Was the syringe tray intact and undamaged on receipt? Yes. If the product came with a cellophane cover, was the cellophane covering the syringe tray intact and completely sealed? Yes. Was the syringe carton damaged prior to use? (i.e. crushed, ripped, unglued) No. Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? Yes.  If complaint sample is not/cannot be returned, please provide reason: Sample was thrown away in a biohazard box after the incident and is therefore unavailable.  Ask for Order Information: Agent will reach out to HCP for this information.  o Provide Order and/or Invoice Number as well as ask for copy of the order/invoice to be emailed to agent will reach out to HCP for this information. o If purchased from wholesaler, ask for wholesaler information (wholesaler name, address, contact name) agent will reach out to HCP for this information. o Ask for carrier name if purchased from wholesaler agent will reach out to HCP for this information.  If photos are available, ask the customer to send them to email address provided photos are unavailable as HCP did not take any prior to disposing of syringe.  o Ask for photos of shipping container, carton of syringes showing serialization number, lot number and Expiry date and defective syringe(s)  Retrieval Information: Obtain Defective syringe (broken or cracked), unused syringes within the carton, carton, and trays (both trays within the carton) -Document what can be retrieved in case description and/or notes.  Expedite return for cracked syringes. If there is a doubt whether it is cracked or broken, please expedite.   NOTE: Vaccine Prefilled Syringes including Sterile Diluent Syringes may be returned even if biohazardous.