BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD PRO SAFETY IV CATHETERS

    MDR report key: 11498574 · Received March 16, 2021

    Report

    Report Number
    2243072-2021-00805
    Event Type
    Malfunction
    Date Received
    March 16, 2021
    Date of Event
    February 16, 2021
    Report Date
    May 28, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THERE WAS NO SAMPLE OR PHOTO PROVIDED TO BD FOR EVALUATION. THEREFORE, BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION TO VERIFY THE REPORTED ISSUE. A DEVICE HISTORY RECORD COULD NOT BE EVALUATED AS THE LOT NUMBER IS UNKNOWN. CAPA#1379444 WAS INITIATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 UNSPECIFIED BD PRO SAFETY IV CATHETERS EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HI, WE HAVE HAD CASES OF LEAKAGE FROM THE INJECTION PORTS OF BD PRO SAFETY IV IN OUR TRUST.

    Additional Manufacturer Narrative · 1

    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 IN (B)(4) HAS BEEN LISTED. AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 3 UNSPECIFIED BD PRO SAFETY IV CATHETERS EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HI, WE HAVE HAD CASES OF LEAKAGE FROM THE INJECTION PORTS OF BD PRO SAFETY IV IN OUR TRUST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392541 UNSPECIFIED BD PRO SAFETY IV CATHETERS INTERVASCULAR CATHETER FOZ BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1