BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II 22GAX1.00IN PRN SLM NPVC

    MDR report key: 13239934 · Received January 12, 2022

    Report

    Report Number
    3014704491-2021-00441
    Event Type
    Malfunction
    Date Received
    January 12, 2022
    Date of Event
    December 16, 2021
    Report Date
    December 23, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
    Product Code
    FOZ
    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

    INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1203256. 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 · 0

    IT WAS REPORTED THAT BD INTIMA-II 22GAX1.00IN PRN SLM NPVC LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AFTER THE EXAMINATION, THE HEMOSTATIC CLIP OF INDWELL NEEDLE FAILED TO STOP BLEEDING, RESULTING IN BLOOD LEAKAGE AND TENSION OF THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1101247 BD INTIMA-II 22GAX1.00IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 1203256

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown