BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD CATHETER

    MDR report key: 11069368 · Received December 23, 2020

    Report

    Report Number
    2243072-2020-02157
    Event Type
    Malfunction
    Date Received
    December 23, 2020
    Date of Event
    November 27, 2020
    Report Date
    March 2, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THERE WAS NO SAMPLE OR PHOTO AVAILABLE TO BD FOR EVALUATION. THEREFORE, BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION TO VERIFY THE REPORTED ISSUE. SINCE, AN INVESTIGATION COULD NOT BE PERFORMED BD WAS UNABLE TO DETERMINE A POSSIBLE ROOT CAUSE. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS THE LOT NUMBER WAS UNKNOWN. SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UNSPECIFIED BD¿ CATHETER WAS DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CLIENT REPORTS: "BD ANGIOCATH: TERRIBLE CATHETER, THE TIP DOES NOT CLOSE THE ACCESS! WHICH MAKES THE JOB WRONG, BECAUSE IF THE ANIMAL WANTS TO URINATE, IT HAS TO GO WITH THE SERUM TOGETHER, IT IS NOT VIABLE TO CROSS THE SKIN TO THE VESSEL , BAD YELLOW, PINK OR DARK BLUE COLOR! "

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UNSPECIFIED BD¿ CATHETER WAS DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CLIENT REPORTS: "BD ANGIOCATH: TERRIBLE CATHETER, THE TIP DOES NOT CLOSE THE ACCESS! WHICH MAKES THE JOB WRONG, BECAUSE IF THE ANIMAL WANTS TO URINATE, IT HAS TO GO WITH THE SERUM TOGETHER, IT IS NOT VIABLE TO CROSS THE SKIN TO THE VESSEL , BAD YELLOW, PINK OR DARK BLUE COLOR!"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1530693 UNSPECIFIED BD CATHETER CATHETER FOZ BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1