BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML LL S/C 48

    MDR report key: 19875210 · Received July 31, 2024

    Report

    Report Number
    1911916-2024-00557
    Event Type
    Malfunction
    Date Received
    July 31, 2024
    Date of Event
    July 28, 2024
    Report Date
    September 4, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903028307
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR (B)(4) FOLLOW UP: IT WAS REPORTED THERE WERE INCORRECT SYRINGE MARKINGS. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS A SYRINGE WITH NO PACKAGING BLISTER. THE SYRINGE HAS THE SCALE MARKING SHIFTED. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF THERE WAS A JAM DURING THE SYRINGE BARREL PRINTING PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302830, LOT 4122296. THE REVIEW REVEALED THERE WERE NO ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT, THOUGH IT WAS DOCUMENTED THAT A REPAIR TO THE SYRINGE BARREL PRINTING PROCESS WAS PERFORMED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. VERIFICATION OF THE SYRINGE BARREL PRINTING PROCESS WAS PERFORMED. THE SETTINGS WERE CORRECT, AND THE FLOW OF PRODUCT WAS GOOD. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED MATERIAL#: 302830; BATCH#: 4122296. IT WAS REPORTED BY THE CUSTOMER THAT SYRINGE IN THEIR BOX WITH INCORRECT SYRINGE MARKINGS. VERBATIM: ONE OF OUR HOSPITALS FOUND THIS SYRINGE IN THEIR BOX WITH INCORRECT SYRINGE MARKINGS ADDITIONAL INFO: 1. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO ISSUE WAS DETECTED BEFORE IV PREP COMPLETED, A DIFFERENT UNAFFECTED SYRINGE WAS USED INSTEAD. 2. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? 28-007-2024. 3. TOTAL NUMBER OF OCCURRENCES? 1.

    Description of Event or Problem · 0

    MATERIAL#: 302830, BATCH#: 4122296. IT WAS REPORTED BY THE CUSTOMER THAT SYRINGE IN THEIR BOX WITH INCORRECT SYRINGE MARKINGS VERBATIM: ONE OF OUR HOSPITALS FOUND THIS SYRINGE IN THEIR BOX WITH INCORRECT SYRINGE MARKINGS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957326 SYRINGE 20ML LL S/C 48 SYRINGE, PISTON FMF BECTON DICKINSON 4122296 30382903028307

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown