BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HSCT KOR IV SET TPE GFR SS 5UM P 3W R AP

    MDR report key: 11335381 · Received February 16, 2021

    Report

    Report Number
    2243072-2021-00328
    Event Type
    Malfunction
    Date Received
    February 16, 2021
    Date of Event
    September 18, 2020
    Report Date
    March 10, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: AFTER FURTHER REVIEW, THIS COMPLAINT WILL BE CANCELLED, AS THIS PRODUCT IS NOT A MARKETED DEVICE IN THE US.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HSCT KOR IV SET TPE GFR SS 5UM P 3W R AP LEAKED FROM THE DRIP CHAMBER WHILE BEING TESTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "USERS TESTING THE PRODUCT FOUND 1 X DRIP CHAMBER LEAK."

    Additional Manufacturer Narrative · 1

    OEM MANUFACTURER: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED. AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE REPORTED LOT # [20200725] WAS NOT FOUND FOR THE REPORTED CATALOG # [388063]. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HSCT KOR IV SET TPE GFR SS 5UM P 3W R AP LEAKED FROM THE DRIP CHAMBER WHILE BEING TESTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "USERS TESTING THE PRODUCT FOUND 1 X DRIP CHAMBER LEAK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228999 HSCT KOR IV SET TPE GFR SS 5UM P 3W R AP INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1