BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 19208067 · Received April 29, 2024

    Report

    Report Number
    1710034-2024-00371
    Event Type
    Malfunction
    Date Received
    April 29, 2024
    Date of Event
    April 2, 2024
    Report Date
    August 21, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825233
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 382523 AND LOT NUMBER 4037557. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT HAS BEEN BROUGHT TO OUR ATTENTION THAT EITHER, LAWSON # 133750 IV EXT SET W/2 NEDL FREE SITES REF# 37262E OR LAWSON # 104516 NEEDLE IV AUTOGUARD 22G REF # 382532 IS LEAKING. THEY COULD NOT DUPLICATE THE ISSUE WITH DIFFERENT ITEMS BUT ARE CONCERNED. JUST WANTED YOU TO BE AWARE IN CASE ANY OTHER TEAM MEMBERS ARE REPORTING ISSUES WE ARE EXPERIENCE LEAKING WITH EITHER ITEM # 37262E OR 382532 IN THE ED. CAN YOU PLEASE HELP AT XXXX? CUSTOMER RESPONSE FOR FOLLOW-UP: 1. ON OR AROUND 4-2-24 2. THE DEPT DID NOT KNOW FOR SURE WHICH ITEM WAS LEAKING FOR SURE. 3. ITEM # 133750 LOT # IS 24029188 & ITEM # 104516 LOT # 4037557. 4. NO HARM WAS DONE. 5. NO 6. ONE OCCURRENCE. COULD NOT DUPLICATE LEAKAGE. 7. I HAVE THE PACKAGING OF THE TWO ITEMS BUT NOT THE ACTUAL PRODUCT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1419869 BD INSYTE AUTOGUARD INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4037557 00382903825233

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown