BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 17560442 · Received August 16, 2023

    Report

    Report Number
    3014704491-2023-00456
    Event Type
    Malfunction
    Date Received
    August 16, 2023
    Date of Event
    July 10, 2023
    Report Date
    August 27, 2023
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    K200891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 3080077. 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

    H.3. 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 A HOLE WAS FOUND IN THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM WHILE ADMINISTERING IV FLUIDS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "ON (B)(6), 2023, WHILE ADMINISTERING IV FLUIDS TO A CHILD WITH AN INDWELLING NEEDLE, A GUNSHOT WOUND WAS FOUND OUTSIDE THE HOSE OF THE INDWELLING NEEDLE AND THE NEEDLE WAS REPLACED FOR IV FLUIDS... (B)(6), 2023, WHEN GIVING INTRAVENOUS INFUSION TO A CHILD WITH AN INDWELLING NEEDLE, IT WAS FOUND THAT THERE WAS A PUNCTURE OUTSIDE THE HOSE OF THE INDWELLING NEEDLE, SO THE INDWELLING NEEDLE WAS REPLACED FOR INTRAVENOUS INFUSION."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A HOLE WAS FOUND IN THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM WHILE ADMINISTERING IV FLUIDS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "ON (B)(6), 2023, WHILE ADMINISTERING IV FLUIDS TO A CHILD WITH AN INDWELLING NEEDLE, A GUNSHOT WOUND WAS FOUND OUTSIDE THE HOSE OF THE INDWELLING NEEDLE AND THE NEEDLE WAS REPLACED FOR IV FLUIDS... ON (B)(6), 2023, WHEN GIVING INTRAVENOUS INFUSION TO A CHILD WITH AN INDWELLING NEEDLE, IT WAS FOUND THAT THERE WAS A PUNCTURE OUTSIDE THE HOSE OF THE INDWELLING NEEDLE, SO THE INDWELLING NEEDLE WAS REPLACED FOR INTRAVENOUS INFUSION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1933197 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 3080077

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown