BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUCATH ACE INTRAVASCULAR CATHETER (18G)

    MDR report key: 21023403 · Received December 26, 2024

    Report

    Report Number
    3006260740-2024-07799
    Event Type
    Malfunction
    Date Received
    December 26, 2024
    Date of Event
    October 23, 2024
    Report Date
    March 25, 2025
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    FOZ
    UDI-DI
    00801741138003
    PMA / PMN Number
    K162894
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    BECTON DICKINSON AND COMPANY'S (BD) MEDICATION DELIVERY SOLUTIONS (MDS) BUSINESS UNIT WILL DISCONTINUE MALFUNCTION MDR REPORTING FOR CERTAIN DEVICE FAILURES THAT HAVE NOT CAUSED OR CONTRIBUTED TO DEATHS OR SERIOUS INJURIES IN THE PAST TWO YEARS, AND WHERE THE LIKELIHOOD OF A DEATH OR SERIOUS INJURY AS A RESULT OF THESE MALFUNCTIONS IS REMOTE. THIS DECISION FOLLOWS FDA GUIDELINES (MEDICAL DEVICE REPORTING FOR MANUFACTURERS GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF ISSUED NOV 8, 2016, REFERENCE SECTION 2.15). BD NOTIFIED FDA OF THIS DECISION ON MAR 3, 2025. FDA HAS REVIEWED AND RESPONDED TO BD¿S NOTIFICATION (REFERENCE FDA DOCUMENT # (B)(4)) ON MARCH 7, 2025. THIS DOCUMENTATION IS AVAILABLE IN BD DOCUMENT MANAGEMENT SYSTEM (SAP). THIS SUPPLEMENTAL MDR IS BEING FILED TO DOCUMENT THAT THE BELOW DEVICE FAILURE WILL NO LONGER BE CONSIDERED A REPORTABLE MALFUNCTION MDR FOR THE PRODUCT FAMILY BELOW: PRODUCT FAMILY: ACCCATH ACE. DEVICE FAILURE: GUIDEWIRE / STYLET BENT.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA MEDWATCH THAT WHILE ATTEMPTING TO PLACE AN 18G ACCUCATH IN PATIENT'S LAC, THE ACCUCATH GUIDEWIRE APPEARED TO FISHHOOK AND BECAME LODGED UNDER PATIENT'S SKIN. PA WAS CONTACTED. PA MADE SMALL SKIN NIK AND WIRE WAS REMOVED INTACT. DRESSING OF GAUZE AND TAPE APPLIED. PATIENT TOLERATED WELL. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1995535 ACCUCATH ACE INTRAVASCULAR CATHETER (18G) CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ C.R. BARD, INC. (BASD) -3006260740 N/A REJR1631 00801741138003

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Other