BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD SHIELDED IV CATHETER

    MDR report key: 16678395 · Received April 4, 2023

    Report

    Report Number
    1710034-2023-00360
    Event Type
    Malfunction
    Date Received
    April 4, 2023
    Date of Event
    March 17, 2023
    Report Date
    May 9, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903815111
    PMA / PMN Number
    K013800
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: (B)(6), 2023 H6: INVESTIGATION SUMMARY BD RECEIVED AN UNSEALED 24 GAUGE INSYTE AUTOGUARD WINGED UNIT FROM LOT 3002689 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 UNIT AND OBSERVED THAT THE NEEDLE WAS BENT AT AROUND A 90 DEGREES ANGLE. THE NEEDLE COVER ALSO APPEARED TO HAVE MULTIPLE SCRATCHES ON THE FRONT, SIDES AND BACK. THEREFORE, BASED OFF THE VISUAL INSPECTION THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. DUE TO THE BENT NEEDLE, THE NEEDLE WAS UNABLE TO RETRACT FULLY. UNFORTUNATELY, THE ENGINEER COULD NOT DETERMINE THE EXACT CAUSE FOR THE BENT NEEDLE. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H3. 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 · 0

    IT WAS REPORTED THAT THE BD INSYTE AUTOGUARD SHIELDED IV CATHETER NEEDLE PARTIALLY RETRACTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DO NOT HAVE THIS PRODUCT, 24GA IV CATH, 381511 LOT 3002689 AFTER AN IV ATTEMPT AND THE NURSE WAS GETTING READY TO DISCARD THE CATHETER THE SAFETY BUTTON WAS PRESSED TO RETRACT THE NEEDLE AND THE CATHETER GOT CAUGHT AND WAS STUCK ON THE NEEDLE AND NOT ABLE TO RETRACT ALL THE WAY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE AUTOGUARD SHIELDED IV CATHETER NEEDLE PARTIALLY RETRACTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DO NOT HAVE THIS PRODUCT, 24GA IV CATH, 381511 LOT 3002689 AFTER AN IV ATTEMPT AND THE NURSE WAS GETTING READY TO DISCARD THE CATHETER THE SAFETY BUTTON WAS PRESSED TO RETRACT THE NEEDLE AND THE CATHETER GOT CAUGHT AND WAS STUCK ON THE NEEDLE AND NOT ABLE TO RETRACT ALL THE WAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403879 BD INSYTE AUTOGUARD SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3002689 00382903815111

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown