BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    24G X 0.75IN (0.7 X 19 MM) INSYTE AUTOGUARD BC

    MDR report key: 9405815 · Received December 3, 2019

    Report

    Report Number
    1710034-2019-01289
    Event Type
    Malfunction
    Date Received
    December 3, 2019
    Date of Event
    November 13, 2019
    Report Date
    January 13, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825128
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. 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-CONFORMANCES 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 WAS REPORTED THAT LEAKAGE OCCURRED DURING USE WITH A 24G X 0.75IN (0.7 X 19 MM) INSYTE AUTOGUARD BC. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "PER EMAIL: SORRY TO ONLY CONTACT YOU WHEN I HAVE ISSUES BUT I HAVE ANOTHER LARGE PAIN CLINIC THAT USES YOUR INSYTE AUTOGUARD PRODUCT AND IS HAVING ISSUES WITH THEM LEAKING ALSO . THE PRODUCT NUMBER IS 382512 AND THE LOT NUMBER WAS 9190483. THEY ALSO USE THE 22 GAUGE BUT HAVE NOT HAD ANY PROBLEM WITH THAT SIZE. THE CONTACT THERE IS IN THE MAIN CLINIC AREA. HAVE YOU HEARD IF YOU HAVE HAD ANY PROBLEMS WITH THIS LOT NUMBER AND PRODUCT NUMBER. THEY HAVE OPENED A COUPLE DIFFERENT BOXES AND HAVE HAD A FEW LEAK FROM BOTH OF THEM. THEY STILL HAVE 5 MORE BOXES THAT I TOLD THEM TO HOLD ONTO UNTIL I COULD SPEAK TO YOU. PLEASE LET ME KNOW YOUR THOUGHTS AND THEN WE CAN FIGURE OUT HOW TO PROCEED FROM THERE."

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEAKAGE OCCURRED DURING USE WITH A 24G X 0.75IN (0.7 X 19 MM) INSYTE AUTOGUARD BC. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "PER EMAIL: SORRY TO ONLY CONTACT YOU WHEN I HAVE ISSUES BUT I HAVE ANOTHER LARGE PAIN CLINIC THAT USES YOUR INSYTE AUTOGUARD PRODUCT AND IS HAVING ISSUES WITH THEM LEAKING ALSO. THE PRODUCT NUMBER IS 382512 AND THE LOT NUMBER WAS 9190483. THEY ALSO USE THE 22 GAUGE BUT HAVE NOT HAD ANY PROBLEM WITH THAT SIZE. THE CONTACT THERE IS IN THE MAIN CLINIC AREA. HAVE YOU HEARD IF YOU HAVE HAD ANY PROBLEMS WITH THIS LOT NUMBER AND PRODUCT NUMBER. THEY HAVE OPENED A COUPLE DIFFERENT BOXES AND HAVE HAD A FEW LEAK FROM BOTH OF THEM. THEY STILL HAVE 5 MORE BOXES THAT I TOLD THEM TO HOLD ONTO UNTIL I COULD SPEAK TO YOU. PLEASE LET ME KNOW YOUR THOUGHTS AND THEN WE CAN FIGURE OUT HOW TO PROCEED FROM THERE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1201697 24G X 0.75IN (0.7 X 19 MM) INSYTE AUTOGUARD BC INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 382512 9190483 30382903825128

    Patients

    Seq Age Sex Outcome Treatment
    1 Other