BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8437874 · Received March 20, 2019

    Report

    Report Number
    3006948883-2019-00200
    Event Type
    Malfunction
    Date Received
    March 20, 2019
    Date of Event
    February 20, 2019
    Report Date
    April 11, 2019
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    UNKNOWN
    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 SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8171135. 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 AFTER INJECTION OF AN UNSPECIFIED BD INTIMA-II¿ Y 24GAX0.75IN PRN/EC SLM THERE WAS BLOOD RETURN AT THE INJECTION SITE.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. 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. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER INJECTION OF AN UNSPECIFIED BD INTIMA-II¿ Y 24GAX0.75IN PRN/EC SLM THERE WAS BLOOD RETURN AT THE INJECTION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229499 UNSPECIFIED BD INTIMA-II¿ Y 24GAX0.75IN PRN/EC SLM CATHETER FOZ BD (SUZHOU) 8171135

    Patients

    Seq Age Sex Outcome Treatment
    1 Other