BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ Y 18GAX1.16IN PRN EC SLM NPVC

    MDR report key: 8575482 · Received May 2, 2019

    Report

    Report Number
    3006948883-2019-00334
    Event Type
    Malfunction
    Date Received
    May 2, 2019
    Date of Event
    April 17, 2019
    Report Date
    May 22, 2019
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 7202087. 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. UNFORTUNATELY A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING. WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS LEAKAGE WITH A BD INTIMA-II¿ Y 18GAX1.16IN PRN EC SLM NPVC. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: PATIENT FEEDBACK NEEDLE DUL AND FELT PAIN, BLOOD LEAKAGE AT PRN CONNECTOR SITE WHEN PUNCTURE SUCCESSFULLY AND TIGHTEN THE CLAMP.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: UNKNOWN. 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 · 1

    IT WAS REPORTED THAT THERE WAS LEAKAGE WITH A BD INTIMA-II¿ Y 18GAX1.16IN PRN EC SLM NPVC. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: PATIENT FEEDBACK NEEDLE DUL AND FELT PAIN, BLOOD LEAKAGE AT PRN CONNECTOR SITE WHEN PUNCTURE SUCCESSFULLY AND TIGHTEN THE CLAMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369593 BD INTIMA-II¿ Y 18GAX1.16IN PRN EC SLM NPVC INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 7202087

    Patients

    Seq Age Sex Outcome Treatment
    1 Other