BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 14604656 · Received June 6, 2022

    Report

    Report Number
    1710034-2022-00289
    Event Type
    Malfunction
    Date Received
    June 6, 2022
    Date of Event
    May 10, 2022
    Report Date
    July 27, 2022
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818341
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    CORRECTION: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER WAS BROKEN AND WOULD NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE WAS BROKEN AND WOULD NOT RETRACT. MEDICAL DEVICE BRAND NAME: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER MEDICAL DEVICE TYPE: FOZ COMMON DEVICE NAME: INTRAVASCULAR CATHETER INVESTIGATION SUMMARY BD RECEIVED A 20 GAUGE INSYTE AUTOGUARD DEVICE FROM LOT 1236879 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 NOT FULLY RETRACTED. NEXT, MICROSCOPIC INSPECTION FOUND THAT THE GRIP OF THE DEVICE WAS ADHERED TO THE NEEDLE HUB PREVENTING RETRACTION. BASED OFF THE VISUAL AND MICROSCOPIC INSPECTION THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD GENERAL PURPOSE SYRINGE, 5ML, LUER LOCK TIP WITHOUT SAFETY WAS BROKEN AND WOULD NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE WAS BROKEN AND WOULD NOT RETRACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER WAS BROKEN AND WOULD NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE WAS BROKEN AND WOULD NOT RETRACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416759 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381834 1236879 00382903818341
    889524 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381834 1236879 00382903818341

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown