BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ INSYTE AUTOGUARD

    MDR report key: 8438480 · Received March 20, 2019

    Report

    Report Number
    1710034-2019-00316
    Event Type
    Malfunction
    Date Received
    March 20, 2019
    Date of Event
    March 5, 2019
    Report Date
    March 11, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903814238
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. REPORT SOURCE: MEDWATCH 5083802. INVESTIGATION SUMMARY: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLE, BATCH, OR LOT CODE WAS PROVIDED. INVESTIGATION CONCLUSION: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLE, BATCH, OR LOT CODE WAS PROVIDED. ROOT CAUSE DESCRIPTION: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLE, BATCH, OR LOT CODE WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD¿ INSYTE AUTOGUARD HAD LEAKAGE AT THE IV TUBING CONNECTION. CUSTOMER¿S VERBATIM: ¿ IV CATHETER LEAKING AT IV TUBING CONNECTION. IV CATHETER WAS ATTACHED TO IV TUBING. IV TUBING NEEDED EXTRA TIGHTENING TO PREVENT A LEAK AT THE IV CATHETER FEMALE HUB. NO HARM CAME TO PATIENT AND THE IV DID NOT HAVE TO BE REPLACED. THIS WAS REPORTED AT THE TIME OF THE EVENT TO HAVE OCCURRED ON PRIOR OCCASIONS. ¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228268 BD¿ INSYTE AUTOGUARD INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN 30382903814238

    Patients

    Seq Age Sex Outcome Treatment
    1 Other