BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 9587864 · Received January 14, 2020

    Report

    Report Number
    3006948883-2019-01201
    Event Type
    Malfunction
    Date Received
    January 14, 2020
    Date of Event
    December 6, 2019
    Report Date
    February 27, 2020
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9170852. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. UNFORTUNATELY A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING. WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. BD WILL CONTINUE TO MONITOR THIS ISSUE AND ENCOURAGES YOU TO SUBMIT YOUR SAMPLE FOR REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM LEAKED. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FLUID LEAKAGE WAS FOUND IN THE INDWELLING NEEDLE DURING INFUSION, SO THE NEEDLE WAS REPLACED AND RE-PUNCTURED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM LEAKED. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FLUID LEAKAGE WAS FOUND IN THE INDWELLING NEEDLE DURING INFUSION, SO THE NEEDLE WAS REPLACED AND RE-PUNCTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52678 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM CATHETER FOZ BD (SUZHOU) 9170852

    Patients

    Seq Age Sex Outcome Treatment
    1 Other