BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II CLOSED IV CATHETER SYSTEM

    MDR report key: 17722653 · Received September 11, 2023

    Report

    Report Number
    3014704491-2023-00539
    Event Type
    Malfunction
    Date Received
    September 11, 2023
    Date of Event
    August 3, 2023
    Report Date
    September 16, 2023
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903830831
    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

    H.6. INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 3080063. 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. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INTIMA-II CLOSED IV CATHETER SYSTEM THE TUBING CLAMP WAS LOOSE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2023, A CLOSED INTRAVENOUS INDWELLING NEEDLE WAS USED FOR THE PATIENT'S INTRAVENOUS INFUSION. AFTER THE INFUSION WAS COMPLETED, THE NURSE SEALED THE TUBE. THE PATIENT PULLED OUT THE INDWELLING NEEDLE, AND IT WAS FOUND THAT THE LIQUID STOP CLIP WAS NOT TIGHT ENOUGH.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INTIMA-II CLOSED IV CATHETER SYSTEM THE TUBING CLAMP WAS LOOSE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2023, A CLOSED INTRAVENOUS INDWELLING NEEDLE WAS USED FOR THE PATIENT'S INTRAVENOUS INFUSION. AFTER THE INFUSION WAS COMPLETED, THE NURSE SEALED THE TUBE. THE PATIENT PULLED OUT THE INDWELLING NEEDLE, AND IT WAS FOUND THAT THE LIQUID STOP CLIP WAS NOT TIGHT ENOUGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2146953 BD INTIMA-II CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 3080063 00382903830831

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown