BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA II¿ IV CATHETER PRN ADAPTER

    MDR report key: 15764168 · Received November 9, 2022

    Report

    Report Number
    3014704491-2022-00559
    Event Type
    Malfunction
    Date Received
    November 9, 2022
    Date of Event
    September 28, 2022
    Report Date
    November 10, 2022
    Manufacturer
    BD (SUZHOU)
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY . A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1020006. 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; IN LIEU OF THE AFFECTED DEVICE, FUNCTIONAL TESTING WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RESULTS OF THESE SHOW THAT THE TESTED UNITS PERFORMED WITHIN PRODUCT SPECIFICATIONS. UNFORTUNATELY WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT THE BD INTIMA II¿ IV CATHETER PRN ADAPTER EXPERIENCED A DAMAGED TUBING CLAMP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT WAS GIVEN INTRAVENOUS INFUSION AS INSTRUCTED BY THE DOCTOR. DURING USE, IT WAS FOUND THAT THE BUCKLE OF THE INDWELLING NEEDLE WAS BROKEN AND COULD NO LONGER BE USED. THE CLOSED INTRAVENOUS INDWELLING NEEDLE WAS REPLACED IMMEDIATELY AND THE OPERATION WAS COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA II¿ IV CATHETER PRN ADAPTER EXPERIENCED A DAMAGED TUBING CLAMP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT WAS GIVEN INTRAVENOUS INFUSION AS INSTRUCTED BY THE DOCTOR. DURING USE, IT WAS FOUND THAT THE BUCKLE OF THE INDWELLING NEEDLE WAS BROKEN AND COULD NO LONGER BE USED. THE CLOSED INTRAVENOUS INDWELLING NEEDLE WAS REPLACED IMMEDIATELY AND THE OPERATION WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2954607 BD INTIMA II¿ IV CATHETER PRN ADAPTER INTRAVASCULAR CATHETER FPA BD (SUZHOU) 1020006

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown