BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LL W/NDL 22X1-1/2 RB

    MDR report key: 10752231 · Received October 28, 2020

    Report

    Report Number
    1213809-2020-00756
    Event Type
    Malfunction
    Date Received
    October 28, 2020
    Date of Event
    October 2, 2020
    Report Date
    October 13, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903095743
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(4). INVESTIGATION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 12 SYRINGES 3ML LL W/NDL 22X1-1/2 RB LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT MEDICATION LEAKED NEAR THE PLUNGER ROD AREA. EVENT DESCRIPTION PER SNOW VERBATIM STATES: ECONSUMER REPORTED, WHEN SHE WAS DRAWING UP MEDICATION, IT LEAKED NEAR THE PLUNGER ROD AREA 12 SYRINGES AFFECTED. LOT: 0121703, (CONSUMER HAS POOR EYESIGHT). CATALOG: 309574. DATE OF EVENT: UNKNOWN. SAMPLES: YES. MEDICATION: B-12 CL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1217750 SYRINGE 3ML LL W/NDL 22X1-1/2 RB PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309574 0121703 30382903095743

    Patients

    Seq Age Sex Outcome Treatment
    1 Other