BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20G X 1.00IN (1.1 X 25 MM) INSYTE AUTOGUARD BC

    MDR report key: 8567015 · Received April 30, 2019

    Report

    Report Number
    1710034-2019-00474
    Event Type
    Malfunction
    Date Received
    April 30, 2019
    Date of Event
    April 15, 2019
    Report Date
    June 20, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    OUR QUALITY ENGINEER INSPECTED THE SAMPLE AND PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED ONE USED INSYTE AUTOGUARD BC 20GA RETRACTED NEEDLE/SAFETY BARREL ASSEMBLY AND NEEDLE COVER; CATALOG NUMBER 381033, LOT NUMBER 8020660. THE STATED LOT NUMBER 8020660 WAS FOUND NOT VALID. FIVE PHOTOGRAPHS WERE ALSO SUBMITTED. THROUGH THE VISUAL/MICROSCOPIC EVALUATION, THE NEEDLE WAS RETRACTED AND THE WHITE BUTTON WAS DEPRESSED. THE NEEDLE WAS THEN REASSEMBLED TO THE OUT POSITION. BD OBSERVED NO MECHANICAL/PHYSICAL DAMAGE TO ANY OF THE COMPONENTS (SPRING, NEEDLE HUB, GRIPS) OR EVIDENCE OF ADHESIVE ON THE BUTTON OR HUB. A FUNCTIONAL TEST WAS PERFORMED WHERE THE RETRACTION WAS SUCCESSFUL. THE RETURNED UNIT PROVIDED FOR EVALUATION MET AND PERFORMED PER THE REQUIRED MANUFACTURING SPECIFICATIONS. THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE FAILURES STATED IN THE REPORT. THE REPORTED LOT NUMBER 8020660; DOES NOT EXIST FOR MATERIAL 381033. A DHR COULD NOT BE PERFORMED AS A RESULT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 20G X 1.00IN (1.1 X 25 MM) INSYTE AUTOGUARD BC EXPERIENCED A RETRACTION ISSUE WITH THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE DIDN'T RETRACT PROPERLY. A FEW NEEDLE TIP CAME OUT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. DEVICE EXPIRATION DATE: UNKNOWN. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 20G X 1.00IN (1.1 X 25 MM) INSYTE AUTOGUARD BC EXPERIENCED A RETRACTION ISSUE WITH THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE DIDN'T RETRACT PROPERLY. A FEW NEEDLE TIP CAME OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360662 20G X 1.00IN (1.1 X 25 MM) INSYTE AUTOGUARD BC INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other