BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAY BONANNO CATHETER S/SU

    MDR report key: 12450355 · Received September 9, 2021

    Report

    Report Number
    2618282-2021-00053
    Event Type
    Malfunction
    Date Received
    September 9, 2021
    Date of Event
    August 12, 2021
    Report Date
    April 28, 2025
    Manufacturer
    BD CARIBE LTD.
    Product Code
    FEZ
    UDI-DI
    00382904082895
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES D.9. RETURNED TO MANUFACTURER ON: 9/23/2021 H.6. INVESTIGATION: BASED ON THE SAMPLE PROVIDED TO BD FOR EVALUATION, THE REPORTED CONDITION WAS VERIFIED. A POTENTIAL ROOT CAUSE WAS ALSO IDENTIFIED WITH SAMPLE EVIDENCE SHOWING THE CATHETER SLEEVE MAY NOT HAVE BEEN POSITIONED CORRECTLY. 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. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED, AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. POTENTIAL ROOT CAUSE CAN BE DIRECTED TO POSSIBLE HANDLING ISSUES BASED ON THE EVALUATION OF THE SAMPLE RECEIVED. AS PER COMPLAINT SAMPLE EVIDENCE HAS A NOTABLE TORE AT THE END OF THE CATHETER IN WHICH COULD BE AN INDICATIVE THAT THE CATHETER SLEEVE WAS NOT POSITIONED CORRECTLY.

    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 10000690801. 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: CATHETER DAMAGED / DEFECTIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE TRAY BONANNO CATHETER S/SU, THE DEVICE EXPERIENCED THE CATHETER BREAKING APART. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: PLASTIC SHEATH AROUND THE NEEDLE SEEMS TO BE TORN.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    LOT#: BATCH 105452 DOES NOT EXIST FOR MATERIAL NUMBER 408289. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE TRAY BONANNO CATHETER S/SU, THE DEVICE EXPERIENCED THE CATHETER BREAKING APART. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: PLASTIC SHEATH AROUND THE NEEDLE SEEMS TO BE TORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1347338 TRAY BONANNO CATHETER S/SU SUPRAPUBIC UROLOGICAL CATHETER ACCES. FEZ BD CARIBE LTD. 408289 SEE H.10. 00382904082895

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown