BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 8773612 · Received July 9, 2019

    Report

    Report Number
    1710034-2019-00734
    Event Type
    Malfunction
    Date Received
    July 9, 2019
    Date of Event
    June 18, 2019
    Report Date
    July 17, 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
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER NEEDLE FAILED TO RETRACT DURING USE. NO DATE/TIME OR PATIENT INFORMATION WAS GIVEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 381434 BATCH NO. 9021528. IT WAS REPORTED THAT A NEEDLE FAILED TO RETRACT. PER EMAIL: WE RECENTLY HAD A 20 GA AUTOGUARD NOT BE ABLE TO RETRACT. I AM ASSUMING THIS IS AN ISOLATED INCIDENT. THIS HAS ONLY HAPPENED ONCE AND I HAVE HEARD OF NO RECALLS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER NEEDLE FAILED TO RETRACT DURING USE. NO DATE/TIME OR PATIENT INFORMATION WAS GIVEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 381434 BATCH NO. 9021528. IT WAS REPORTED THAT A NEEDLE FAILED TO RETRACT. PER EMAIL: WE RECENTLY HAD A 20 GA AUTOGUARD NOT BE ABLE TO RETRACT. I AM ASSUMING THIS IS AN ISOLATED INCIDENT. THIS HAS ONLY HAPPENED ONCE AND I HAVE HEARD OF NO RECALLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565458 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9021528 30382903814344

    Patients

    Seq Age Sex Outcome Treatment
    1 Other