BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 9405632 · Received December 3, 2019

    Report

    Report Number
    3006948883-2019-01008
    Event Type
    Malfunction
    Date Received
    December 3, 2019
    Date of Event
    October 20, 2019
    Report Date
    December 17, 2019
    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

    INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9141672. 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. A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING. TWO RETAINED SAMPLES WERE EVALUATED FOR LEAKAGE AND BOTH PASSED. WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LEAKAGE OCCURRED DURING USE WITH A BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "DURING THE PROCESS OF INTRAVENOUS INFUSION, THE INDWELLING NEEDLE LEAKAGE WAS EXPLAINED TO THE PATIENT AFTER REMOVAL AND THE INDWELLING NEEDLE WAS REPLACED."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEAKAGE OCCURRED DURING USE WITH A BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "DURING THE PROCESS OF INTRAVENOUS INFUSION, THE INDWELLING NEEDLE LEAKAGE WAS EXPLAINED TO THE PATIENT AFTER REMOVAL AND THE INDWELLING NEEDLE WAS REPLACED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1201613 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 9141672

    Patients

    Seq Age Sex Outcome Treatment
    1 Other