BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 24GA 0.75IN (0.7 X 19 MM)

    MDR report key: 9622731 · Received January 23, 2020

    Report

    Report Number
    1710034-2020-00021
    Event Type
    Malfunction
    Date Received
    January 23, 2020
    Date of Event
    January 3, 2020
    Report Date
    February 27, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903814122
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY 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-CONFORMANCE'S ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 24GA 0.75IN (0.7 X 19 MM) HAS BEEN FOUND DAMAGED DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED HOLES IN THE SIDE OF THE IV AND DIFFICULT INSERTION. PER EMAIL: HOSPITAL REPORTED AN ISSUE WITH REF 381412 AND LOT 9163650. THEY COMPLAINED OF REPORTED "HOLES" IN THE SIDES OF THE IV'S. I BELIEVE THIS WAS FROM RETHREADING BUT THEY ALSO COMPLAINED OF DIFFICULT INSERTION.

    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.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 24GA 0.75IN (0.7 X 19 MM) HAS BEEN FOUND DAMAGED DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED HOLES IN THE SIDE OF THE IV AND DIFFICULT INSERTION. PER EMAIL: HOSPITAL REPORTED AN ISSUE WITH REF 381412 AND LOT 9163650. THEY COMPLAINED OF REPORTED "HOLES" IN THE SIDES OF THE IV'S. I BELIEVE THIS WAS FROM RETHREADING BUT THEY ALSO COMPLAINED OF DIFFICULT INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88221 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 24GA 0.75IN (0.7 X 19 MM) INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381412 9163650 30382903814122

    Patients

    Seq Age Sex Outcome Treatment
    1 Other