BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD BC

    MDR report key: 18778831 · Received February 26, 2024

    Report

    Report Number
    1710034-2024-00135
    Event Type
    Malfunction
    Date Received
    February 26, 2024
    Date of Event
    October 31, 2023
    Report Date
    February 25, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825234
    PMA / PMN Number
    K110443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. LOT 3222135 MFG 2023-08-11 EXP 2026-07-31. LOT 3145633 MFG 2023-06-20 EXP 2026- 05-31. INVESTIGATION FINDINGS: THE COMPLAINT OF THREADING DIFFICULTY WAS CONFIRMED DUE TO THE CIRCUMSTANTIAL EVIDENCE OF CATHETER TIP DAMAGE, WHICH APPEARED TO BE MANUFACTURING RELATED. THREE 22G INSYTE AUTOGUARD CATHETERS WERE RECEIVED WITH SIX NEEDLES AND SEVEN OPEN UNIT PACKAGES. THE UNIT LABELS WERE FROM LOTS 3222135, 3145633, AND 3192272. TWO OF THE THREE CATHETERS EXHIBITED DAMAGE AT THE CATHETER TIP THAT APPEARED TO BE CAUSED BY POOR TIP FORMATION. NO DEFECTS WERE OBSERVED AT THE NEEDLE TIPS. THE APPROPRIATE MANUFACTURING PERSONNEL WERE NOTIFIED OF THE CATHETER TIP DAMAGE, WHICH LIKELY CONTRIBUTED TO THE REPORTED EVENTS. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD BC DOES NOT THREAD THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CATHETER WILL NOT THREAD AFTER ACCESS WITH THE NEEDLE. THE NEEDLE ITSELF IS MORE RESISTANT TO PIERCING THE SKIN AND THEN, ONCE IN, ADVANCING THE CATHETER IS DIFFICULT TO DO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1920428 BD INSYTE AUTOGUARD BC PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3192272 30382903825234

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown