BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 19312457 · Received May 14, 2024

    Report

    Report Number
    1710034-2024-00436
    Event Type
    Malfunction
    Date Received
    May 14, 2024
    Date of Event
    February 26, 2024
    Report Date
    May 14, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818129
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR REPLACES MFR REPORT # 9610048-2024-0003. E. FACILITY NAME CHARACTER LIMIT IS EXCEEDED: (B)(6) CENTRE. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION RESULTS: THE REPORTED DEFECT COULD NOT BE REFUTED NOR CONFIRMED IN THE ABSENCE OF A SAMPLE. THE ROOT CAUSE CANNOT BE DETERMINED FOR AN UNCONFIRMED DEFECT. DHR FOR LOT NUMBER 3222137 HAS BEEN REVIEWED. SUBASSEMBLY LOT 3222137 AND MATERIAL 700IAGS12 WAS BUILT ON AFA LINE 4 FROM 16AUG2023 THROUGH 20AUG2023. THIS LOT WAS PACKAGED ON PKG LINE 19 FROM 16AUG2023 THROUGH 16AUG2023 USING THE FINAL LOT NUMBER 3222137, MATERIAL NUMBER 381812 FOR A QUANTITY OF (B)(4) UNITS. NO RELATED QUALITY ISSUES OR PROCESS DEVIATIONS WERE FOUND.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD LEAKS PAST THE SEPTUM THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I WAS RECEIVING MEDICAL CARE (TRANSFUSION) AT (B)(6) CENTRE MONDAY MORNING (B)(6) 2024. I HAVE RECEIVED THIS TYPE OF MEDICAL CARE FOR YEARS; THEREFORE I GOT TO KNOW THE HOSPITAL NURSING STAFF. MONDAY MORNING THE HEAD NURSE WAS TRAINING A NEW EMPLOYEE TO PROPERLY PROGRAM THE PUMP MACHINE TO ADMINISTER THE CARE I HAD AN APPOINTMENT FOR. AS SHE WALKED HIM THROUGH THE PROCESS SHE INSTALLED MY IV CATHETER. I SHARED WITH HER HOW AMAZED I WAS ABOUT BD'S INSYTE AUTOGUARD BC SHIELDED IV CATHETER WITH BLOOD CONTROL TECHNOLOGY PUSH-BUTTON NEEDLE SHIELDING TECHNOLOGY AND FULLY ENCAPSULATED NEEDLE WHICH SHE AGREED WITH. WHICH SHE PARTIALLY AGREED WITH. SHE USED A "BLUE" BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER WITH BLOOD CONTROL TECHNOLOGYINSYTE AUTOGUARD IV CATHETER ON ME. SHE SAID THE "BLUE" ONES WORKED WELL. STILL SHE SHARED DISSATISFACTION WITH THE "YELLOW" BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER WITH BLOOD CONTROL TECHNOLOGYINSYTE AUTOGUARD IV CATHETERS AS THE DEVICE'S SAFETY MECHANISM AND BLOOD CONTROL TECHNOLOGY PREVENTING/ STOPPING BLOOD LEAKAGE WAS NOT WORKING HE REPORTED BLOOD LEAKAGE AT INSERTION STAFF EXPOSURE TO BLOOD AND SURFACE CONTAMINATION WHENEVER THEY USED THE "YELLOW" ONES. SHE GAVE ME A "YELLOW" ONE TO ALLOW ME TO ESCALATE THIS MATTER WITHIN BD. SHE SAID SHE DID NOT KNOW WHO HER BD SALES REP WAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474862 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3222137 00382903818129

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown