BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 8804747 · Received July 18, 2019

    Report

    Report Number
    1710034-2019-00782
    Event Type
    Malfunction
    Date Received
    July 18, 2019
    Date of Event
    July 2, 2019
    Report Date
    September 3, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818235
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD RECEIVED TWO 22 GAUGE INSYTE AUTOGUARD UNITS FROM LOT 9010577 FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNITS AND OBSERVED DAMAGE ON THE THREADS OF THE LUER ADAPTER FOR THE FIRST UNIT AND NO DAMAGE TO THE SECOND UNIT. BASED OFF THE VISUAL INSPECTION THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. THE OBSERVED DAMAGE WAS DETERMINED TO HAVE BEEN A MANUFACTURING DEFECT. THE OBSERVED DAMAGE WAS CAUSED BY A MISALIGNMENT BETWEEN THE ADAPTER AND THE MANUFACTURING EQUIPMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE THE CATHETER ADAPTER WOULD NOT CONNECT TO THE DEVICE WITH A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: HCP COULDN'T CONNECT OTHER DEVICE TO THE CATHETER ADAPTER.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: UNKNOWN. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE THE CATHETER ADAPTER WOULD NOT CONNECT TO THE DEVICE WITH A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: HCP COULDN'T CONNECT OTHER DEVICE TO THE CATHETER ADAPTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594990 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9010577 00382903818235

    Patients

    Seq Age Sex Outcome Treatment
    1 Other