Age: 9.0
Sex: U
Vaccine: PNC15
Symptoms: Accident at work, Skin laceration, Syringe issue
Clinical narrative: No adverse event; Broken Syringe; Flange - Broken During or After injection; FBE called on behalf of physician to report 1 broken pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE) syringe. Per FBE, physician reported they were attempting to administer product when the syringe broke and cut their hand. FBE stated physician did not provide them with any further details. Agent placed outbound call and spoke directly with physician. 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. Physician stated she has cuts to her index and middle finger on her right hand from the syringe breaking. Physician stated none of the product actually got injected into the patient. PQC and AE for injury to physician documented in this case. See case #02592645 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 pictures. 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 RA: o 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. o 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).  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:  o Is the syringe broken into 2 or more pieces? YES, "HARD TO SAY HOW MANY PIECES", HALF OF FINGER FLANGE "SHATTERED OFF" o If yes, describe in detail how it is broken: (e.g. shattered, broken in half etc.) SHATTERED 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 , finger flange back-stop) o If yes, describe in detail how it is broken. HALF OF FINGER FLANGE SHATTERED o Provide the exact location of the breakage on the syringe? FINGER FLANGE o Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? NO (if yes describe in detail) o Is there difficulty attaching the Syringe Needle to the Syringe? NO o If Yes, describe the type of issue you are experiencing in detail. o Was the syringe needle attached or being attached to the syringe tip when the issue or breakage was noted or occurred? YES, NEEDLE ATTACHED o If the issue involves the Syringe Needle or attachment issues: o Was the Needle supplied by Merck? YES/NO/NA/UNSPECIFIED o Identify the Brand and Type of needle that was used: (e.g. BP, Safety needle/Blunt Needle etc.) o What was the Size and Gauge of the needle (e.g. 25g, 5/8 in) o Was anyone injured as a result of the breakage? YES o If yes, provide brief description of injury PHYSICIAN WAS CUT ON INDEX AND MIDDLE FINGER OF RIGHT HAND BY BROKEN SYRINGE o Note to CSR: Report an AE if yes as outlined in Instruction section  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? YES/NO/NA/UNSPECIFIED o Is there any broken glass or other separated component in the tray? (if yes specify)  o After removing the syringe from the tray? NO  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  o 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, WAS ATTEMPTING TO ADMINISTER WHEN SYRINGE BROKE. ALSO, BROKEN SYRINGE CUT PHYSICIAN'S HAND  o 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  o Ask for Order Information: NO ORDER INFORMATION AVAILABLE o Provide Order and/or Invoice Number as well as ask for copy of the order/invoice to be emailed o If purchased from wholesaler, ask for wholesaler information (wholesaler name, address, contact name) o Ask for carrier name if purchased from wholesaler  o If photos are available, ask the customer to send them NO PHOTOS ARE AVAILABLE o Ask for photos of shipping container, carton of syringes showing serialization number, lot number and expiry date and defective syringe(s)  Retrieval Information: o 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 o 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. 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 has been reviewed and attached to report. - As per RA '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.  This case one of 2 cases notified by the same reporter. The other one captured in E2B linked report US-009507513-2405USA000301 and refers to the physician. ; Sender's Comments:  US-009507513-2405USA000301