BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II Y 22GAX1.00IN PRN/EC SLM

    MDR report key: 12242809 · Received July 28, 2021

    Report

    Report Number
    3006948883-2021-00837
    Event Type
    Malfunction
    Date Received
    July 28, 2021
    Date of Event
    May 31, 2021
    Report Date
    July 14, 2021
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    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 · 1

    INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED BY YOUR FACILITY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 0231181. 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. BD WILL CONTINUE TO MONITOR THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTIMA-II Y 22GAX1.00IN PRN/EC SLM LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AT 9:00 ON THE MORNING, EXTRAVASATION OF FLUID WAS FOUND ALONG THE PUNCTURING SITE. THE INDWELLING NEEDLE WAS PULLED OUT IMMEDIATELY AND LEAKAGE WAS FOUND AT THE INTERFACE BETWEEN THE FRONT END OF THE INDWELLING NEEDLE AND THE NEEDLE HANDLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1134078 INTIMA-II Y 22GAX1.00IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 0231181

    Patients

    Seq Age Sex Outcome Treatment
    1