BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 9213716 · Received October 21, 2019

    Report

    Report Number
    1710034-2019-01127
    Event Type
    Malfunction
    Date Received
    October 21, 2019
    Date of Event
    October 4, 2019
    Report Date
    November 27, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903815129
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER BLOOD MOVES THROUGH THE PORT AND INTO THE TUBING. THIS OCCURRED ON 2 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 381512 BATCH NO.: 9140903 . IT WAS REPORTED THAT BLOOD MOVES THROUGH THE PORT AND INTO THE TUBING. PER COMPLAINT FORM: WE HAVE HAD TWO INCIDENTS WITH THE ABOVE IV CATH. WHEN THE NURSES INSERT THE CATHETER, THE BLOOD MOVES THROUGH THE PORT AND INTO THE TUBING.

    Additional Manufacturer Narrative · 1

    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 BLOOD MOVES THROUGH THE PORT AND INTO THE TUBING. THIS OCCURRED ON 2 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 381512. BATCH NO.: 9140903. IT WAS REPORTED THAT BLOOD MOVES THROUGH THE PORT AND INTO THE TUBING. PER COMPLAINT FORM: WE HAVE HAD TWO INCIDENTS WITH THE ABOVE IV CATH. WHEN THE NURSES INSERT THE CATHETER, THE BLOOD MOVES THROUGH THE PORT AND INTO THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010649 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9140903 30382903815129

    Patients

    Seq Age Sex Outcome Treatment
    1 Other