BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUCATH, ACE 20GX2.25

    MDR report key: 17389594 · Received July 25, 2023

    Report

    Report Number
    3006260740-2023-03159
    Event Type
    Malfunction
    Date Received
    July 25, 2023
    Date of Event
    July 10, 2023
    Report Date
    March 25, 2025
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    FOZ
    UDI-DI
    00801741137952
    PMA / PMN Number
    K162894
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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

    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. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF A DAMAGED CATHETER IS CONFIRMED AND WAS DETERMINED TO BE USE RELATED. THE PRODUCT RETURNED FOR EVALUATION WAS 20 G BY 2.25-INCH ACCUCATH ACE PERIPHERAL IV CATHETER ASSEMBLY. THE DEVICE WAS RECEIVED ASSEMBLED. USAGE RESIDUE WAS OBSERVED THROUGHOUT THE CATHETER, GUIDEWIRE, AND NEEDLE. THE SAFETY MECHANISM BUTTON HAD BEEN PRESSED AND THE NEEDLE WAS PARTIALLY WITHDRAWN INTO THE HOUSING. THE CATHETER WAS CRUMPLED ON THE GUIDEWIRE AND ADHERED TO THE NEEDLE SHAFT. THROUGH GENTLE MANIPULATION THE CATHETER WAS REMOVED FROM THE NEEDLE AND GUIDEWIRE WHICH ALLOWED THE NEEDLE TO FULLY WITHDRAW INTO THE HOUSING. MICROSCOPIC INSPECTION OF THE CATHETER CONFIRMED SEVERE DEFORMATION. INSPECTION OF THE DISTAL END OF THE CATHETER REVEALED BUCKLING OF THE CATHETER TIP. INSPECTION OF THE DISTAL END OF THE GUIDEWIRE REVEALED MISALIGNMENT OF THE COILS BUT THE GUIDEWIRE WAS INTACT. A BEND WAS OBSERVED IN THE GUIDEWIRE NEAR THE EXIT SITE OF THE NEEDLE TIP. THIS COMPLAINT WILL BE RECORDED FOR FUTURE TRENDING AND MONITORING PURPOSES. H3 OTHER TEXT : EVALUATION FINDINGS ARE IN SECTION H.11.

    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: CATHETER DIFFICULT TO REMOVE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER THAT A NURSE PLACING AN ACCUCATH IN THE ANTECUBITAL WAS UNABLE TO REMOVE THE DEVICE AFTER THE FAILED ATTEMPT, DUE TO THE GUIDEWIRE NOT RETRACTING, AND WAS MET WITH RESISTANCE. NO OTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER THAT A NURSE PLACING AN ACCUCATH IN THE ANTECUBITAL WAS UNABLE TO REMOVE THE DEVICE AFTER THE FAILED ATTEMPT, DUE TO THE GUIDEWIRE NOT RETRACTING, AND WAS MET WITH RESISTANCE. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2255290 ACCUCATH, ACE 20GX2.25 CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ C.R. BARD, INC. (BASD) -3006260740 N/A UNKNOWN 00801741137952

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other