BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AN UNSPECIFIED BD¿ INTIMA II

    MDR report key: 8436965 · Received March 20, 2019

    Report

    Report Number
    3006948883-2019-00197
    Event Type
    Malfunction
    Date Received
    March 20, 2019
    Date of Event
    January 23, 2019
    Report Date
    April 15, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8141408. 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. 2 RETAINED SAMPLES WERE TESTED FOR LEAKAGE AND PASSED. 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 AN UNSPECIFIED BD¿ INTIMA II WAS CRACK AT THE ADAPTOR LEADING TO REPEATEDLY PUNCTURE. CUSTOMER¿S VERBATIM: ¿ IT WAS FOUND ADAPTOR CRACK LEADING TO REPEATEDLY PUNCTURE.¿

    Additional Manufacturer Narrative · 1

    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 AN UNSPECIFIED BD INTIMA II WAS CRACK AT THE ADAPTOR LEADING TO REPEATEDLY PUNCTURE. CUSTOMER¿S VERBATIM: ¿ IT WAS FOUND ADAPTOR CRACK LEADING TO REPEATEDLY PUNCTURE.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231894 AN UNSPECIFIED BD¿ INTIMA II CATHETER FOZ BD (SUZHOU) 8141408

    Patients

    Seq Age Sex Outcome Treatment
    1 Other