BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 19000648 · Received March 28, 2024

    Report

    Report Number
    1710034-2024-00257
    Event Type
    Malfunction
    Date Received
    March 28, 2024
    Date of Event
    March 4, 2024
    Report Date
    April 30, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818235
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. THE DHR FOR LOT 3251086 WAS REVIEWED. SUBASSEMBLY LOT 3251086 MATERIAL 700IAGS23 WAS BUILT ON AFA LINE 5 FROM 23SEP2023 THROUGH 28SEP2023. FINAL LOT WAS PACKAGED ON PKG LINE 11 FROM 26SEP2023 THROUGH 01OCT2023 FOR A TOTAL QUANTITY OF (B)(4). NO RELATED QUALITY ISSUES OR PROCESS DEVIATIONS WERE FOUND. THIS COMPLAINT TYPE WILL CONTINUE TO BE TRENDED WITHIN THE POST MARKET SURVEILLANCE PROCESS AND ANY DETERMINED ESCALATION WILL BE MANAGED THERE.

    Additional Manufacturer Narrative · 0

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM CHINESE TO ENGLISH: WHEN THE PATIENT WAS GIVEN AN ANALGESIC PUMP TO INJECT A SAFETY 22G NEEDLE ON (B)(6) 2024, THE NEEDLE COULD NOT BE RETRACTED INTO THE CATHETER AFTER THE CATHETER WAS INSERTED, AND THE NEEDLE CORE NEEDED TO BE WITHDRAWN MANUALLY. THIS EVENT CARRIES THE RISK OF CATHETER FAILURE AND NEEDLE STICK INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1370356 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3251086 00382903818235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown