BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II CLOSED IV CATHETER SYSTEM

    MDR report key: 10171272 · Received June 18, 2020

    Report

    Report Number
    3006948883-2020-00247
    Event Type
    Malfunction
    Date Received
    June 18, 2020
    Date of Event
    May 22, 2020
    Report Date
    June 29, 2020
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    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 9170833. 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 UNITS WERE 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM EXPERIENCED LEAKAGE PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE JOINT OF INDWELLING NEEDLE WAS FOUND TO LEAK WHEN EXAUSTING THE AIR.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM EXPERIENCED LEAKAGE PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE JOINT OF INDWELLING NEEDLE WAS FOUND TO LEAK WHEN EXHAUSTING THE AIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636011 BD INTIMA-II CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER FOZ BD (SUZHOU) 9170833

    Patients

    Seq Age Sex Outcome Treatment
    1 Other