BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFICED BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 17466667 · Received August 4, 2023

    Report

    Report Number
    2243072-2023-01379
    Event Type
    Malfunction
    Date Received
    August 4, 2023
    Date of Event
    July 7, 2023
    Report Date
    August 10, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED.  THE LOT NUMBER IS UNKNOWN, THEREFORE DEVICE HISTORY RECORD REVIEW (DHR) OR QUALITY NOTIFICATION REVIEW (QN) COULD NOT BE PERFORMED. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    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 FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. .4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNSPECIFICED BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM WAS LEAKING. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: VERBATIM: AT 10 O'CLOCK ON (B)(6), 2023, WHEN THE NURSE WAS PREPARING THE INDWELLING NEEDLE FOR THE PATIENT, SHE FOUND THAT THE INDWELLING NEEDLE HOSE WAS LEAKING WHEN FLUSHING THE INDWELLING NEEDLE ACCORDING TO THE NORMAL OPERATION PROCESS, AND IMMEDIATELY REPLACED THE INDWELLING NEEDLE WITHOUT USING IT. NO HARM WAS CAUSED TO THE PATIENT, AND THE COST OF THE DEPARTMENT WAS INCREASED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNSPECIFIED BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM WAS LEAKING. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: VERBATIM: AT 10 O'CLOCK ON (B)(6) 2023, WHEN THE NURSE WAS PREPARING THE INDWELLING NEEDLE FOR THE PATIENT, SHE FOUND THAT THE INDWELLING NEEDLE HOSE WAS LEAKING WHEN FLUSHING THE INDWELLING NEEDLE ACCORDING TO THE NORMAL OPERATION PROCESS, AND IMMEDIATELY REPLACED THE INDWELLING NEEDLE WITHOUT USING IT. NO HARM WAS CAUSED TO THE PATIENT, AND THE COST OF THE DEPARTMENT WAS INCREASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1810549 UNSPECIFICED BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown