BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD¿ CATHETER

    MDR report key: 9355476 · Received November 21, 2019

    Report

    Report Number
    3006948883-2019-00956
    Event Type
    Malfunction
    Date Received
    November 21, 2019
    Date of Event
    October 8, 2019
    Report Date
    December 11, 2019
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    FOZ
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A SAMPLE HAS NOT YET BEEN SUBMITTED FOR EVALUATION AND TESTING, PREVENTING BD ENGINEERS FROM CONDUCTING A FULL INVESTIGATION AND DETERMINING A ROOT CAUSE OF THE FAILURE MODE IDENTIFIED IN THE DESCRIPTION OF THE EVENT. THE LOT NUMBER PROVIDED COULD NOT BE ASSOCIATED WITH ANY OF THE PRODUCTS MANUFACTURED BY BD. SINCE A VALID LOT NUMBER COULD NOT BE CONNECTED TO THE DEVICE IDENTIFIED IN THE COMPLAINT, BD INVESTIGATORS COULD NOT CONDUCT A DEVICE HISTORY REVIEW FOR THIS EVENT.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT ONE UNSPECIFIED BD¿ CATHETER HAS BEEN FOUND EXPERIENCING LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: THE PATIENT WAS GIVEN A CLOSED INTRAVENOUS INDWELLING NEEDLE BECAUSE OF NEPHRITIS, AND THE PISTON WAS FLUSHED OUT OF THE INDWELLING NEEDLE CONNECTOR WHEN THE INDWELLING NEEDLE WAS INJECTED WITH ENHANCED CT. THE BD INDWELLING NEEDLE WAS REPLACED IMMEDIATELY WITHOUT THE ABOVE SITUATION.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE LOT #: 8011153 WAS REPORTED BUT IS NOT VALID FOR THIS PRODUCT. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT ONE UNSPECIFIED BD¿ CATHETER HAS BEEN FOUND EXPERIENCING LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: THE PATIENT WAS GIVEN A CLOSED INTRAVENOUS INDWELLING NEEDLE BECAUSE OF NEPHRITIS, AND THE PISTON WAS FLUSHED OUT OF THE INDWELLING NEEDLE CONNECTOR WHEN THE INDWELLING NEEDLE WAS INJECTED WITH ENHANCED CT. THE BD INDWELLING NEEDLE WAS REPLACED IMMEDIATELY WITHOUT THE ABOVE SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154044 UNSPECIFIED BD¿ CATHETER CATHETER FOZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other