BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H10

    MDR report key: 11345790 · Received February 18, 2021

    Report

    Report Number
    1710034-2021-00126
    Event Type
    Malfunction
    Date Received
    February 18, 2021
    Date of Event
    January 22, 2021
    Report Date
    March 8, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE SAMPLE AND PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED ONE USED NEEDLE ASSEMBLY THAT HAD BEEN RETRACTED AND A PACKAGE LABEL FROM REF (B)(4), LOT NUMBER 0174326 AND TWO PHOTOS. THE CATHETER/ ADAPTER ASSEMBLY WAS NOT RETURNED; THEREFORE OBSERVATIONS AND TESTING COULD NOT BE PERFORMED. THE REPORTED DEFECT COULD NOT BE CONFIRMED IN THE ABSENCE OF THE CATHETER/ ADAPTER ASSEMBLY. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. H3 OTHER TEXT: SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY 24GA 0.75IN EXPERIENCED A BLOOD CONTROL FEATURE THAT WOULD NOT WORK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER:ACCORDING TO THE CUSTOMER'S REPORT, THE BLOOD CONTROL VALVE DIDN'T WORK WHEN INSERTING THE CATHETER INTO A VESSEL.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE BRAND NAME: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY 24GA 0.75IN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY 24GA 0.75IN EXPERIENCED A BLOOD CONTROL FEATURE THAT WOULD NOT WORK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCORDING TO THE CUSTOMER'S REPORT, THE BLOOD CONTROL VALVE DIDN'T WORK WHEN INSERTING THE CATHETER INTO A VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241030 SEE H10 INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 0147326

    Patients

    Seq Age Sex Outcome Treatment
    1