BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 9979745 · Received April 20, 2020

    Report

    Report Number
    3006948883-2020-00138
    Event Type
    Malfunction
    Date Received
    April 20, 2020
    Date of Event
    March 21, 2020
    Report Date
    April 27, 2020
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903830831
    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LEAKAGE OCCURRED DURING USE WITH A BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, THE PATIENT PLACED ONE INDWELLING NEEDLE ON (B)(6) 2020 09:10, AND THE INFUSION WAS UNOBTRUSIVE. AT 18:10 ON (B)(6) 2020, FLUID OOZED AT THE JOINT OF THE INDWELLING NEEDLE, THE INDWELLING ROOT WAS SLIGHTLY TWISTED, AND THE INFUSION WAS REMOVED. ANOTHER INDWELLING NEEDLE WAS REPLACED, AND THE INFUSION WAS UNOBTRUSIVE."

    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 LEAKAGE OCCURRED DURING USE WITH A BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, THE PATIENT PLACED ONE INDWELLING NEEDLE ON (B)(6) 2020 09:10, AND THE INFUSION WAS UNOBTRUSIVE. AT 18:10 ON (B)(6) 2020, FLUID OOZED AT THE JOINT OF THE INDWELLING NEEDLE, THE INDWELLING ROOT WAS SLIGHTLY TWISTED, AND THE INFUSION WAS REMOVED. ANOTHER INDWELLING NEEDLE WAS REPLACED, AND THE INFUSION WAS UNOBTRUSIVE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442665 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 9233914 00382903830831

    Patients

    Seq Age Sex Outcome Treatment
    1 Other