BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD SHIELDED IV CATHETER

    MDR report key: 10347914 · Received July 30, 2020

    Report

    Report Number
    1710034-2020-00481
    Event Type
    Malfunction
    Date Received
    July 30, 2020
    Date of Event
    July 10, 2020
    Report Date
    September 8, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903814337
    PMA / PMN Number
    K952861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 LEAKED BLOOD ON 10 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: (B)(6)BATCH NO: 0051690 IT WAS REPORTED THAT THE NEEDLES ARE DULL HAVING TROUBLE PUNCTURING SKIN. IT WAS ALSO REPORTED THAT THE BLOOD CONTROL VALVE IS ALLOWING BLOOD TO FLOW.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD SHIELDED IV CATHETER LEAKED BLOOD ON 10 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: (B)(4), BATCH NO: 0051690. IT WAS REPORTED THAT THE NEEDLES ARE DULL HAVING TROUBLE PUNCTURING SKIN. IT WAS ALSO REPORTED THAT THE BLOOD CONTROL VALVE IS ALLOWING BLOOD TO FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812645 BD INSYTE AUTOGUARD SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381433 0051690 30382903814337

    Patients

    Seq Age Sex Outcome Treatment
    1 Other