BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM

    MDR report key: 19762213 · Received July 17, 2024

    Report

    Report Number
    3002601200-2024-00320
    Event Type
    Malfunction
    Date Received
    July 17, 2024
    Date of Event
    June 19, 2024
    Report Date
    June 25, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830336
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IN RESPONSE TO THE EVENT REPORTED BY YOUR FACILITY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 3052735. 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. BD WILL CONTINUE TO MONITOR THIS ISSUE AND ENCOURAGES YOU TO SUBMIT YOUR SAMPLE FOR REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THE BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM LEAKED. ON JUNE 19, 2024, A NURSE IN OUR HOSPITAL USED A CLOSED INTRAVENOUS INDWELLING NEEDLE PRODUCED BY SUZHOU BIDI MEDICAL EQUIPMENT CO., LTD. TO PUNCTURE A PATIENT AND FOUND THAT AFTER THE INDWELLING NEEDLE WAS SUCCESSFULLY PUNCTURED, LEAKAGE WAS VISIBLE FROM THE TRANSPARENT CATHETER DURING INFUSION. AFTER WIPING, IT WAS FOUND THAT THERE WAS STILL LEAKAGE, WHICH SUGGESTED THAT THE PIPELINE WAS DAMAGED. THE INFUSION WAS PAUSED AND THE BD NEEDLE WAS REMOVED. THE INFUSION WAS NORMAL AFTER REPLACING THE INDWELLING NEEDLE WITH A NEW ONE. THIS SITUATION AFFECTED THE WORK OF MEDICAL STAFF AND THE TREATMENT OF PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361796 BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 3052735 00382903830336

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown