BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 17477359 · Received August 7, 2023

    Report

    Report Number
    3014704491-2023-00426
    Event Type
    Malfunction
    Date Received
    August 7, 2023
    Date of Event
    July 13, 2023
    Report Date
    August 11, 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 3080063. 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 THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM TUBING CLAMP WAS LOOSE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "ON (B)(6) 2023, THE PATIENT USED A CLOSED VENOUS INDWELLING NEEDLE DURING INTRAVENOUS INFUSION. AFTER THE INFUSION WAS COMPLETED, THE NURSE SEALED THE TUBE, AND FOUND THAT THE BLOOD RETURN COULD NOT SEAL THE TUBE AFTER CLAMPING THE LIQUID STOP CLAMP, SO THE PATIENT HAD TO REMOVE THE INDWELLING NEEDLE, AND RE-VENIPUNCTURE WAS REQUIRED DURING THE TRANSFUSION, AND THE SUBSEQUENT EXAMINATION FOUND THAT THE FLUID STOP CLAMP WAS NOT TIGHT."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM TUBING CLAMP WAS LOOSE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "ON (B)(6) 2023, THE PATIENT USED A CLOSED VENOUS INDWELLING NEEDLE DURING INTRAVENOUS INFUSION. AFTER THE INFUSION WAS COMPLETED, THE NURSE SEALED THE TUBE, AND FOUND THAT THE BLOOD RETURN COULD NOT SEAL THE TUBE AFTER CLAMPING THE LIQUID STOP CLAMP, SO THE PATIENT HAD TO REMOVE THE INDWELLING NEEDLE, AND RE-VENIPUNCTURE WAS REQUIRED DURING THE TRANSFUSION, AND THE SUBSEQUENT EXAMINATION FOUND THAT THE FLUID STOP CLAMP WAS NOT TIGHT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1385387 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 3080063

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown