BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20G X 1.16IN (1.1 X 30 MM) INSYTE AUTOGUARD BC

    MDR report key: 8805475 · Received July 18, 2019

    Report

    Report Number
    1710034-2019-00787
    Event Type
    Malfunction
    Date Received
    July 18, 2019
    Date of Event
    July 3, 2019
    Report Date
    September 10, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825340
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BD RECEIVED 32 INSYTE AUTOGUARD BLOOD CONTROL 20 GAUGE UNITS FROM LOT 9071749 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 NO PHYSICAL/MECHANICAL DAMAGE TO ANY OF THE UNITS. THE SEPTUMS WERE PROPERLY SEATED AND IN THE CORRECT POSITION. NEXT, A LEAKAGE TEST WAS PERFORMED ON THE 31 UNUSED UNITS AND NO LEAKAGE WAS OBSERVED. THE ONE USED UNIT COULD NOT BE TESTED SINCE IT WAS DETERMINED TO BE CONTAMINATED AND BIOHAZARD. BASED OFF THE VISUAL INSPECTIONS AND TESTING THE ENGINEER WAS UNABLE TO VERIFY THE REPORTED DEFECT. SINCE NO DEFECTS WERE FOUND DURING EVALUATION A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE 20G X 1.16IN (1.1 X 30 MM) INSYTE AUTOGUARD BC HAS BEEN FOUND EXPERIENCING TWO CASES OF LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT BLOOD CAME OUT WHEN ATTEMPTING TO WITHDRAW THE NEEDLE. PER (B)(4): ¿STARTED 20G IV IN LEFT WRIST. ENGAGED BUTTON TO WITHDRAW NEEDLE, BLOOD CAME POURING OUT. SECOND ONE TO FAIL TODAY. NOTHING ATTACHED TODAY.¿

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE 20G X 1.16IN (1.1 X 30 MM) INSYTE AUTOGUARD BC HAS BEEN FOUND EXPERIENCING TWO CASES OF LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT BLOOD CAME OUT WHEN ATTEMPTING TO WITHDRAW THE NEEDLE. PER PIR 3012930: ¿STARTED 20G IV IN LEFT WRIST. ENGAGED BUTTON TO WITHDRAW NEEDLE, BLOOD CAME POURING OUT. SECOND ONE TO FAIL TODAY. NOTHING ATTACHED TODAY.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594937 20G X 1.16IN (1.1 X 30 MM) INSYTE AUTOGUARD BC INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9071749 30382903825340

    Patients

    Seq Age Sex Outcome Treatment
    1 Other