BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER

    MDR report key: 10237807 · Received July 6, 2020

    Report

    Report Number
    1710034-2020-00428
    Event Type
    Malfunction
    Date Received
    July 6, 2020
    Date of Event
    June 16, 2020
    Report Date
    August 11, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825234
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. THE DHR FOR LOT 0051694 HAS BEEN REVIEWED. ONE RELATED QN WAS FOUND, QN# (B)(6). THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETERS EXPERIENCED A BLOOD CONTROL FEATURE THAT DID NOT WORK DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 382523, BATCH NO: 0051694 ISSUE: THREE OF THESE IV CATHETERS' VACUUM FAILED. WHEN RETRACTING NEEDLE AFTER PLACING IV THE CATHETER "HOLDS" THE BLOOD UNTIL TUBING IS HOOKED UP. IN THESE THREE INCIDENCES THE BLOOD FLOWED THROUGH THE CATHETER INSTEAD OF "HOLDING".

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 3 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETERS EXPERIENCED A BLOOD CONTROL FEATURE THAT DID NOT WORK DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 382523, BATCH NO: 0051694. ISSUE: THREE OF THESE IV CATHETERS' VACUUM FAILED. WHEN RETRACTING NEEDLE AFTER PLACING IV THE CATHETER "HOLDS" THE BLOOD UNTIL TUBING IS HOOKED UP. IN THESE THREE INCIDENCES THE BLOOD FLOWED THROUGH THE CATHETER INSTEAD OF "HOLDING".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695582 BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 382523 0051694 30382903825234

    Patients

    Seq Age Sex Outcome Treatment
    1 Other