BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 9979623 · Received April 20, 2020

    Report

    Report Number
    3006948883-2020-00136
    Event Type
    Malfunction
    Date Received
    April 20, 2020
    Date of Event
    February 17, 2020
    Report Date
    April 27, 2020
    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

    H.6. INVESTIGATION SUMMARY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9233914. 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. BD WILL CONTINUE TO MONITOR THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM LEAKED BEFORE USE WHILE INSPECTING THE INDWELLING NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "THE VEIN CHANNEL WAS ESTABLISHED FOR THE PATIENT. THE INDWELLING NEEDLE INTERFACE WAS FOUND TO BE LEAKING DURING THE INSPECTION OF THE INDWELLING NEEDLE. THE NEW INDWELLING NEEDLE WAS REPLACED FOR OPERATION WITHOUT AFFECTING THE CHILD".

    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 THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM LEAKED BEFORE USE WHILE INSPECTING THE INDWELLING NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THE VEIN CHANNEL WAS ESTABLISHED FOR THE PATIENT. THE INDWELLING NEEDLE INTERFACE WAS FOUND TO BE LEAKING DURING THE INSPECTION OF THE INDWELLING NEEDLE. THE NEW INDWELLING NEEDLE WAS REPLACED FOR OPERATION WITHOUT AFFECTING THE CHILD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442662 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 9106899

    Patients

    Seq Age Sex Outcome Treatment
    1 Other