BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LL

    MDR report key: 9262638 · Received October 31, 2019

    Report

    Report Number
    1213809-2019-01087
    Event Type
    Malfunction
    Date Received
    October 31, 2019
    Date of Event
    October 16, 2019
    Report Date
    December 31, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903095859
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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. THE LOT NUMBER IS UNKNOWN, THEREFORE DEVICE HISTORY RECORD REVIEW (DHR) OR QUALITY NOTIFICATION REVIEW (QN) COULD NOT BE PERFORMED.

    Description of Event or Problem · 0

    MATERIAL NO: 309585 BATCH NO: 0053070. IT WAS REPORTED THAT BEFORE USE OF THE SYRINGE 3ML LL THE SYRINGES WERE RECEIVED WITHOUT EXPIRATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE HAVE BEEN HAVING MULTIPLE INSTANCES OF NOT HAVING AN EXPIRATION DATE ON THEIR FLUSH SYRINGES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: N/A. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MATERIAL NO: 309585 BATCH NO: 0053070. IT WAS REPORTED THAT BEFORE USE OF THE SYRINGE 3ML LL THE SYRINGES WERE RECEIVED WITHOUT EXPIRATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE HAVE BEEN MULTIPLE INSTANCES OF NOT HAVING AN EXPIRATION DATE ON THEIR FLUSH SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053261 SYRINGE 3ML LL PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 0053070 30382903095859

    Patients

    Seq Age Sex Outcome Treatment
    1 Other