BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12971818 · Received December 9, 2021

    Report

    Report Number
    3014704491-2021-00341
    Event Type
    Malfunction
    Date Received
    December 9, 2021
    Date of Event
    November 10, 2021
    Report Date
    December 10, 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

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1111451. 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. ALTHOUGH PHOTOS WERE SUBMITTED FOR EVALUATION, THE AFFECTED 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

    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 WHEN USING THE BD INTIMA-II Y 22GAX1.00IN PRN EC SLM NPVC THE NEEDLE BROKE AND DETACHED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE TIP OF THE NEEDLE WAS BROKEN FROM THE WHITE NEEDLE WING DURING THE PUNCTURE PROCESS. THE NEEDLE WING AND THE NEEDLE CORE WERE SEPARATED IN THE PROCESS OF PUSHING THE NEEDLE. THERE WAS NO NEEDLE INJURY."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD INTIMA-II Y 22GAX1.00IN PRN EC SLM NPVC THE NEEDLE BROKE AND DETACHED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE TIP OF THE NEEDLE WAS BROKEN FROM THE WHITE NEEDLE WING DURING THE PUNCTURE PROCESS. THE NEEDLE WING AND THE NEEDLE CORE WERE SEPARATED IN THE PROCESS OF PUSHING THE NEEDLE. THERE WAS NO NEEDLE INJURY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1870625 BD INTIMA-II Y 22GAX1.00IN PRN EC SLM NPVC INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 1111451

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown