BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BONNANO¿ CATHETER

    MDR report key: 12849310 · Received November 19, 2021

    Report

    Report Number
    2618282-2021-00068
    Event Type
    Malfunction
    Date Received
    November 19, 2021
    Date of Event
    October 22, 2021
    Report Date
    April 28, 2025
    Manufacturer
    BD CARIBE LTD.
    Product Code
    FEZ
    UDI-DI
    00382904082895
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: AFTER EVALUATION OF PROVIDED SAMPLE, THE REPORTED FAILURE COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED, AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS INCIDENT AND NO DISCREPANCY OR NON-CONFORMANCE WERE IDENTIFIED THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    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) AS DIR (B)(4). 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: BONNANO. DEVICE FAILURE: ADAPTER / CONNECTOR DAMAGED / DEFECTIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED BD BONNANO¿ CATHETER WAS DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE DR WAS PREPARING AND TESTING CATHETER AS ROUTINE PRIOR TO INSERTION AND NOTICED AN ABNORMAL RESISTANCE WHEN SLIDING NEEDLE OVER CATHETER COMPARED TO THE USUAL FEEL WITH THESE DEVICES. HE FELT IT WAS NOT APPROPRIATE TO PROCEED AND USED ANOTHER DEVICE WITHOUT THIS ISSUE."

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1739335 BD BONNANO¿ CATHETER SUPRAPUBIC UROLOGICAL CATHETER FEZ BD CARIBE LTD. 408289 1060646 00382904082895

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown