Sex: U
Vaccine: PNC15
Symptoms: Syringe issue
Clinical narrative: No injuries occurred as a result of the syringe breaking/  HCP has no additional AE/PQC details.; A single syringe of VAXNEUVANCE broke immediately after administration to a patient; HCP called to report that on 11/28/2023 a single syringe of VAXNEUVANCE broke immediately after administration to a patient, at the sight of the finger flange.; This spontaneous report has been received from a registered nurse, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies were not reported.  On 28-NOV-2023, the patient was vaccinated with a dose of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) injection, at a dose of 0.5 milliliters as prophylaxis (lot number: X020953, which was determined to be valid by the validation lot team, with an expiration date on: 18-OCT-2025) (scheme, route and anatomical location of administration were not reported).  Immediately after the vaccination was performed the syringe broke at the sight of the finger flange entirely off the barrel (Syringe issue).  Health care professional (HCP) reported that the patient received the full dose (Poor quality device used), and no injuries occurred as a result of the syringe breaking (No adverse event).  HCP reported that the product is available for retrieval.  No additional information was reported.   Complaint Description Detail  HCP called to report that on 28-NOV-2023 a single syringe of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) broke immediately after administration to a patient, at the sight of the finger flange. HCP reports that the patient received a full dose, and no injuries occurred as a result of the syringe breaking. HCP reports that after all product was injected the finger flange broke entirely off the barrel of the syringe. HCP reports that the product is available for retrieval. HCP reports demographics for the patient are unavailable. HCP will forward photos to company. HCP requested replacement: SEE CASE 02517513. HCP reports the lot involved as Lot: X020953 & EXP: 18-OCT-2025. HCP has no additional AE/PQC details.  When did the breakage of the prefilled syringe occur? On 25-NOV-2023; at the sight of the finger flange. If injury was result of the breakage  when did the injury occur? No injury reported; dose was administered to a patient.  Where on the prefilled syringe did the breakage occur? (Note for CSR  ask the reporter to be as specific as possible) Finger Flange.  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 CRACKS NOTED BY HCP       If yes, describe the size, shape & depth of the crack N/A       Provide the exact location of the crack on the syringe: N/A   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.) FINGER FLANGE OF SYRINGE BROKE OFF IMMEDIATELY AFTER ADMINISTERING PRODUCT TO A PATIENT. HCP REPORTS THAT THE PATIENT RECIEVED THE FULL DOSE, AND NO INJURIES TO PATIENT OR PROVIDER USING THE VACCINE REPORTED.     Provide the exact location of the breakage on the syringe?  FINGER FLANGE  Does the syringe have a broken component? YES (e.g. broken syringe tip; loose or detached luer lock, or broken finger     If yes, describe in detail how it is broken. BROKEN FINGER FLANGE: FINGER FLANGE BROKE OFF IMMEDIATELY AFTER ADMINITERING PRODUCT TO A PATIENT.            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)    Was anyone injured as a result of the breakage? NO  If yes, provide brief description of injury N/A Note to CSR: Report an AE if yes as outlined in Instruction section N/A          Was there difficulty trying to attach the syringe needle to the syringe? NO     If yes, describe N/A    If yes, was it supplied by MERCK: N/A    If not supplied by MERCK, what type & brand, needle size & gauge was used? N/A  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? N/A       Is there any broken glass or other separated component in the tray? (if yes specify) N/A  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    If no, describe issue: N/A  Was the syringe tray intact and undamaged on receipt? YES   If no, describe damage. N/A  If the product came with a cellophane cover, was the cellophane covering the syringe tray intact and completely sealed?   *See below. YES    If no, describe damage N/A   Was the syringe carton damaged prior to use?  (i.e. crushed, ripped, unglued): NO   If yes, describe N/A  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: SYRINGE IS AVAILABLE FOR RETIEVAL. HCP WILL SET ASIDE FOR RETURN TO MERCK.  *If photos are available, ask the customer to send them to Merck's email. HCP IS FORWARDING PHOTOS OF SYRINGE.  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: 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  05-DEC-2023 14:30 PM :Attachment added to Service Cloud. 05-DEC-2023 14:30 PM :Attachment added to Service Cloud. 05-DEC-2023 14:30 PM :Attachment added to Service Cloud.  05-DEC-2023 14:30 PM :E-mail received in the Contact Center mailbox on 05-DEC-2023 at 12:43 PM with pictures for this case. See attached. 05-DEC-2023 14:30 PM :Attachment added to Service Cloud. 05-DEC-2023 14:30 PM :Awaiting retrieval site from Quality  --  See Attachment  06-DEC-2023: CHU/- Email with image received has been attached in the reference tab.-  The complainant reported that a single syringe of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) broke immediately after administration to a patient, at the sight of the finger flange which has been observed in the shared image. Hence, complaint category   Broken During or After injection >> Secondary Packaging' has been selected and assigned to packaging site for investigation. 06-DEC-2023: CHU/: Second person review done. 06-DEC-2023 09:31 AM: Email received in the PQC Mailbox on 06-DEC-2023 at 4:09 AM with the following from quality: "PQC acknowledged." See attached. 06-DEC-2023 09:31 AM :Attachment added to Service Cloud. 06-DEC-2023 12:30 PM :Attachment added to Service Cloud. 06-DEC-2023 12:30 PM :Retrieval site at location. 06-DEC-2023 12:30 PM :Shipping labels created for location.  Shipped on 12/06/2023.