BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 9491586 · Received December 18, 2019

    Report

    Report Number
    1710034-2019-01342
    Event Type
    Malfunction
    Date Received
    December 18, 2019
    Date of Event
    November 25, 2019
    Report Date
    January 22, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825449
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION: DHR FOR LOT 9071648 HAS BEEN REVIEWED. NO RELATED QUALITY ISSUES OR PROCESS DEVIATIONS WERE FOUND. OBSERVATIONS AND/OR TESTING COULD NOT BE CONDUCTED IN THE ABSENCE OF A SAMPLE. THE ROOT CAUSE CANNOT BE DETERMINED FOR AN UNCONFIRMED DEFECT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT RETRACTION FAILURE OCCURRED DURING USE WITH A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THIS WAS AN IV THAT THEY STARTED ON A PATIENT AND WHEN THEY WENT TO RETRACT THE NEEDLE IT WENT IN BUT NOT ALL THE WAY IN AND THEN "SHOT"BACK OUT AND BLEW THE IV."

    Additional Manufacturer Narrative · 1

    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

    IT WAS REPORTED THAT RETRACTION FAILURE OCCURRED DURING USE WITH A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THIS WAS AN IV THAT THEY STARTED ON A PATIENT AND WHEN THEY WENT TO RETRACT THE NEEDLE IT WENT IN BUT NOT ALL THE WAY IN AND THEN "SHOT"BACK OUT AND BLEW THE IV."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1286659 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 382544 9130556 30382903825449

    Patients

    Seq Age Sex Outcome Treatment
    1 Other