BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 9087152 · Received September 19, 2019

    Report

    Report Number
    1710034-2019-01021
    Event Type
    Malfunction
    Date Received
    September 19, 2019
    Date of Event
    September 3, 2019
    Report Date
    October 18, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903814344
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THERE WERE NO SAMPLES OR PHOTOS AVAILABLE TO BD FOR EVALUATION. THEREFORE, BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION TO VERIFY THE REPORTED ISSUE. SINCE, AN INVESTIGATION COULD NOT BE PERFORMED BD WAS UNABLE TO DETERMINE A POSSIBLE ROOT CAUSE. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION.

    Description of Event or Problem · 0

    MATERIAL NO: 381434, BATCH NO: 9140536. IT WAS REPORTED THAT AFTER USE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER THE NEEDLE WOULD NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE ON 20 GAUGE IV WOULD NOT RETRACT USING RETRACTING BUTTON, STAYED UNRETRACTED. NO HARM TO PT OR STAFF.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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

    MATERIAL NO: 381434 BATCH NO: 9140536. IT WAS REPORTED THAT AFTER USE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER THE NEEDLE WOULD NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE ON 20 GAUGE IV WOULD NOT RETRACT USING RETRACTING BUTTON, STAYED UNRETRACTED. NO HARM TO PT OR STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889797 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9140536 30382903814344

    Patients

    Seq Age Sex Outcome Treatment
    1 Other