BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 8355884 · Received February 20, 2019

    Report

    Report Number
    1710034-2019-00191
    Event Type
    Malfunction
    Date Received
    February 20, 2019
    Date of Event
    February 1, 2019
    Report Date
    March 27, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    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

    INVESTIGATION: REVIEW OF THE DHR¿S REVEALED THAT ALL REQUIRED CHALLENGES SAMPLES, SET-UP AND IN-PROCESS TESTING WAS PERFORMED PER SPECIFICATION IN ACCORDANCE WITH THE QUALITY SAMPLING PLANS. REVIEW DISCLOSED THERE WERE NO RELATED REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT THE OUTCOME OF THE QUALITY OF THE PRODUCT RELEVANT TO THE DEFECT STATED IN THE EVENT DESCRIPTION. RECEIVED ONE UNUSED IAG 20GA CATHETER/ADAPTER ASSEMBLY, A NEEDLE COVER AND AN OPENED EMPTY PACKAGE FROM CATALOG NUMBER: 391934, LOT NUMBER: 8071737. VISUAL/MICROSCOPIC EVALUATION: ONE OF THE SUTURE WINGS WAS MISSING OFF FROM THE ADAPTER. IN THE AREA OF THE MISSING SUTURE WING THE EDGES ARE SMOOTH AND CLEAN. ALSO OBSERVED DAMAGE ON THE NEEDLE COVER. MOLD PROCESS ¿ THE DEFECT WING DAMAGED/DEFECTIVE WAS IDENTIFIED AND CONFIRMED. THE MISSING SUTURE WAS FROM THE MOLD CAVITY NOT RECEIVING ENOUGH MATERIAL. THE DAMAGED OBSERVED ON THE NEEDLE COVER IS NOT RELATED TO THE MISSING SUTURE WING. THE DAMAGED NEEDLE COVER WAS FROM THE MANUFACTURING PROCESS. SINCE THE DAMAGE WAS FOUND DOWNSTREAM THE ORIGINAL DAMAGE SOURCE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER WHEN THE PACKAGE WAS OPENED A SIDE OF THE WING WAS MISSING.

    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 BEFORE USE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER WHEN THE PACKAGE WAS OPENED A SIDE OF THE WING WAS MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149342 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8071737

    Patients

    Seq Age Sex Outcome Treatment
    1 Other