Sex: F
Vaccine: PNC15
Symptoms: Accident at work, Skin laceration, Syringe issue
Clinical narrative: Physician stated she has cuts to her index and middle finger on her right hand from the syringe breaking.; when she went to push the plunger down to administer the product half of the finger flange shattered off and cut her hand. Physician stated she has cuts to her index and middle finger on her right hand from the syringe breaking.; FBE called on behalf of physician to report 1 broken VAXNEUVANCE syringe.; This spontaneous report has been received from a physician, via company representative (Field-Based Employee [FBE]) and refers to herself, a 52-year-old female patient.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 29-APR-2024, the patient (physician) was attempting to administer the vaccine to the patient with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE), 0.5 milliliter injection (formulation: pre-filled syringe) (lot # X019624 has been verified to be valid, expiration date: 07-NOV-2025) administered for prophylaxis (route of administration was not provided) (details regarding the patient who product was being administered to were captured in MARRS # 2404USA012480).  FBE called on behalf of physician to report 1 broken pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) syringe (syringe issue). The physician reported that they were attempting to administer suspect vaccine when the syringe broke and cut their hand. Physician stated that no issues were noted to syringe prior to attempting to administer the vaccine, but when she went to push the plunger down to administer the product half of the finger flange shattered off and cut her hand. The physician stated that she had cuts to her index and middle finger on her right hand from the syringe breaking (skin laceration, injury associated with device). The physician stated that none of the product actually got injected into the patient. Product quality complained (PQC) and adverse event (AE) for injury to physician was documented in this case. FBE stated that physician did not provide them with any further details. The physician stated she disposed of product immediately after break occurred, so it was not available for return, and she did not have any pictures. No additional AE or PQC were reported. There was no crack. The needle was attached when the issue occurred. The syringe tip cap was attached properly prior to use. The syringe carton was not damaged prior to use. At the time of reporting the patient was recovering from the event of skin laceration. The outcome with the event complication associated with device was not provided.  The causal relationship between the events and pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) were unknown.  Complaint description detail FBE called on behalf of physician to report 1 broken pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) syringe. The physician reported that they were attempting to administer suspect vaccine when the syringe broke and cut their hand. Physician stated that no issues were noted to syringe prior to attempting to administer the vaccine, but when she went to push the plunger down to administer the product half of the finger flange shattered off and cut her hand. The physician stated that she had cuts to her index and middle finger on her right hand from the syringe breaking (skin laceration, injury associated with device). The physician stated that none of the product actually got injected into the patient. Product quality complained (PQC) and adverse event (AE) for injury to physician was documented in this case. See other case (MARRS # 2404USA012480) for AE for patient who product was being administered to. Physician stated she disposed of product immediately after break occurred, so it is not available for return, and she does not have any picture. No additional AE/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 craked 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, "HARD TO SAY HOW MANY PIECES", HALF OF FINGER FLANGE "SHATTERED OFF" If yes, describe in detail how it is broken: (e.g. shattered, broken in half etc.) SHATTERED 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 flange, finger flange back  stop). If yes, describe in detail how it is broken. HALF OF FINGER FLANGE SHATTERED 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 in detail) Is there difficulty attaching the Syringe Needle to the Syringe? NO If Yes, describe the type of issue you are experiencing in detail Was the syringe needle attached or being attached to the syringe tip when the issue or breakage was noted or occurred? YES, NEEDLE ATTACHED.  If the issue involves the Syringe Needle or attachment issues: Was the Needle supplied by Merck? YES/NO/NA/UNSPECIFIED Identify the Brand and Type of needle that was used: (e.g. BP, Safety needle/Blunt Needle etc.) What was the Size and Gauge of the needle (e.g. 25g, 5/8 in) Was anyone injured as a result of the breakage? YES If yes, provide brief description of injury PHYSICIAN WAS CUT ON INDEX AND MIDDLE FINGER OF RIGHT HAND BY BROKEN SYRINGE  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 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? YES Immediately after giving the injection? NO  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? See below. 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, WAS ATTEMPTING TO ADMINISTER WHEN SYRINGE BROKE. ALSO, BROKEN SYRINGE CUT PHYSICIAN'S HAND If complaint sample is not/cannot be returned, please provide reason: PHYSICAN STATED THEY DISPOSED OF BROKE SYRINGE IMMEDIATELY SO IT IS NO AVAILABLE FOR RETURN. Ask for order information: NO ODER INFORMATION AVAILABLE.  If photos are available:  NO PHOTOS ARE AVAILABLE.  NOTE: Vaccine Prefilled Syringes including Sterile Diluent 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:  30-APR-2024: As complainant stated 'Physician stated no issues were noted to syringe prior to attempting to administered but when she went to push the plunger down to administer the product half of the finger flange shattered off and cut her hand' hence this report is categorized as 'Broken Syringe > Flange - Broken During or After injection (Secondary Packaging)'. PQC details form received from MNSC has been reviewed and attached to report.  As per MNSC 'NO PHOTOS ARE AVAILABLE' and 'PHYSICAN STATED THEY DISPOSED OF BROKE SYRINGE IMMEDIATELY SO IT IS NO AVAILABLE FOR RETURN.  30-APR-2024: Second person review completed. E-sign to be performed.   Complaint Description Summary PQC - When went to push the plunger down to administer the product half of the finger flange shattered off and cut hand. ; Sender's Comments:  US-009507513-2404USA012480:MSD