BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8668689 · Received June 4, 2019

    Report

    Report Number
    1710034-2019-00593
    Event Type
    Malfunction
    Date Received
    June 4, 2019
    Date of Event
    May 15, 2019
    Report Date
    July 12, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818341
    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 SUMMARY: BD RECEIVED A USED 20 GAUGE INSYTE AUTOGUARD UNIT FROM LOT 8201646 AND 8 PHOTOS FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT AND NO RELATED QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNIT AND OBSERVED THAT THE NEEDLE WAS PARTIALLY RETRACTED AND THE WHITE BUTTON WAS DEPRESSED. THE SPRING APPEARED TO STILL BE BOUND. THE UNIT WAS REASSEMBLED INTO THE OUT POSITION AND THE WHITE BUTTON WAS DEPRESSED AGAIN. THE NEEDLE SUCCESSFULLY RETRACTED. HOWEVER, BASED OFF THE INITIAL INSPECTION OF THE DEVICE THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. THE PROVIDED PHOTOS ALSO SUPPORTED THIS FINDING. THIS WAS DETERMINED TO HAVE BEEN A MANUFACTURING DEFECT AND THE FACILITY HAS BEEN NOTIFIED OF THIS INCIDENT AND THE FINDINGS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 20G X 1.16IN (1.1 X 30 MM) INSYTE AUTOGUARD EXPERIENCED A NEEDLE THAT WOULD NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER CATHETER PLACEMENT, THE NEEDLE DIDN'T RETRACT EVEN PRESSED THE BUTTON.

    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 THE 20 G X 1.16 IN (1.1 X 30 MM) INSYTE AUTOGUARD EXPERIENCED A NEEDLE THAT WOULD NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER CATHETER PLACEMENT, THE NEEDLE DIDN'T RETRACT EVEN PRESSED THE BUTTON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459361 20G X 1.16IN (1.1 X 30 MM) INSYTE AUTOGUARD INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8201646 00382903818341

    Patients

    Seq Age Sex Outcome Treatment
    1 Other