BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO 701 CONTAINER WITH INSULATION

    MDR report key: 7095536 · Received December 7, 2017

    Report

    Report Number
    2243072-2017-00309
    Event Type
    Malfunction
    Date Received
    December 7, 2017
    Date of Event
    December 10, 2015
    Report Date
    November 8, 2017
    Manufacturer
    BECTON DICKINSON
    Product Code
    KER
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE LOT # UNKNOWN; MEDICAL DEVICE EXPIRATION DATE: UNKNOWN; UNIQUE IDENTIFIER (UDI) # UNKNOWN; DEVICE MANUFACTURE DATE: UNKNOWN. RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION. THE DEFECT COULD NOT BE CONFIRMED FROM THE PHOTO. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BIO 701 CONTAINER WITH INSULATION HAD LOCKS THAT WOULDN'T CLOSE CORRECTLY, THEY SEE TO GET LOOSE AND THE CONTAINER CAN NOT BE CLOSED. NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    874423 BIO 701 CONTAINER WITH INSULATION TERTIARY BOX KER BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other