BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNSPECIFIED BD INSYTE IV CATHETER

    MDR report key: 11817045 · Received May 13, 2021

    Report

    Report Number
    2243072-2021-01446
    Event Type
    Injury
    Date Received
    May 13, 2021
    Date of Event
    April 13, 2021
    Report Date
    May 4, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER ADDITIONAL PHONE#: (B)(6). 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 IN (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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN INFECTION ON 10 OCCASIONS WHILE USING UNSPECIFIED BD¿ INSYTE IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: UNKNOWN BATCH NO: UNKNOWN. IT WAS REPORTED VIA POST MARKET SURVEY THAT THE CLINICIAN ENCOUNTERED OCCURRENCES OF BLOODSTREAM INFECTION (E.G. BLOOD STREAM BACTERAEMIA, SEPSIS) (10), PHLEBITIS (5), INFILTRATION / EXTRAVASATION (10), AND CATHETER OCCLUSIONS (5).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718694 UNSPECIFIED BD INSYTE IV CATHETER CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other