Sex: U
Vaccine: PNC15, PNC15, PNC15
Symptoms: No adverse event, Syringe issue
Clinical narrative: no adverse event; Field Based Employee called on behalf of a medical assistant to report that they have had multiple VAXNEUVANCE syringes break after being administered to patients. Employee provided agent with contact number for medical assistant and agent plac; Field Based Employee called on behalf of a medical assistant to report that they have had multiple VAXNEUVANCE syringes break after being administered to patients. Employee provided agent with contact number for medical assistant and agent plac; Complaint Description Detail Company Employee called on behalf of a medical assistant to report that they have had multiple pneumococcal 15v conj vaccine (CRM197)(VAXNEUVANCE), lot # X005583, expiration date: 10-DEC-2024  (strength, formulation, and route of administration were not provided) syringes break after being administered to patients. Employee provided agent with contact number for medical assistant and agent placed outbound call to collect additional information. Agent spoke directly with customer who stated they have had 3 syringes of pneumococcal 15v conj vaccine (CRM197)(VAXNEUVANCE) break in the past 2 weeks all from the same lot number. Customer did not recall the exact dates that the first two syringes broke but stated the 3rd one broke on 29-AUG-2023. Customer stated all three syringes broke after being administered to patients while attempting to put the safety on the needle. Customer stated there were no issues noted with the syringes prior to or during administration and the patients who were administered these products have not had any symptoms. Customer stated no one was injured. Customer stated the 1st and 2nd syringe broke cleanly into 2 pieces at the "neck" just before the luer lock. The 3rd also broke into 2 pieces at the same spot but customer stated there was a sliver of the barrel that broke off with the luer lock piece. Customer stated all 3 syringes were discarded after use so are not available for return and they did not take any pictures prior to discarding. Customer did not want to provide any patient information at time of call. No additional AE/no additional PQC. QUESTION SECTION: Medium Risk: Broken Syringe Barrel High Risk: Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange.. Notes for DPOC: o Is there a crack? NO o If yes, describe the size, shape & depth of the crack: Is the syringe broken into 2 or more pieces? YES o If yes, describe in detail how it is broken: (e.g. shattered, broken in half etc.) at the "neck" just before the luer lock. 1st and 2nd times it was a clean break but the 3rd time a sliver of the barrel was on the luer lock piece. provide the exact location of the breakage on the syringe? where the luer lock and barrel attach. Does the syringe have a broken component? NO Was anyone injured as a result of the breakage? NO Was there difficulty trying to attach the syringe needle to the syringe? 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: not available for return as all 3 syringes were discarcarded immediately after use. Complaint description summary broke into 2 pieces all 3 times at the "neck" just before the luer lock. 1st and 2nd times it was a clean break but the 3rd time a sliver of the barrel was on the luer lock piece.