BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD IAG BC PRO

    MDR report key: 18461411 · Received January 7, 2024

    Report

    Report Number
    1710034-2023-01512
    Event Type
    Malfunction
    Date Received
    January 7, 2024
    Date of Event
    December 11, 2023
    Report Date
    June 26, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903925230
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THE COMPLAINT THAT THE NEEDLE WOULDN'T RETRACT COULD NOT BE CONFIRMED FROM THE REPRESENTATIVE 22GA INSYTE AUTOGUARD BC UNITS THAT WERE RECEIVED IN SEALED PACKAGING FROM LOT #3222379. A FUNCTIONAL TEST SHOWED THAT THE NEEDLES FULLY RETRACTED WHEN THE SAFETY MECHANISM WAS ACTIVATED. NO DAMAGE OR DEFECTS WERE NOTED ON THE RETURNED SAMPLES. ALTHOUGH THE REPRESENTATIVE SAMPLES AND MANUFACTURING RECORDS DO NOT SUPPORT THE COMPLAINANT¿S DESCRIPTION OF THE REPORTED EVENT, THE COMPLAINT HAS BEEN DOCUMENTED AND WILL CONTINUE TO BE MONITORED AS PART OF ONGOING EFFORTS TO IDENTIFY POTENTIAL MANUFACTURING RELATED ISSUES.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. HOWEVER, A TREND HAS BEEN IDENTIFIED FOR THE REPORTED FAILURE AND CORRECTIVE ACTIONS HAVE BEEN INITIATED TO INVESTIGATE THIS TYPE OF INCIDENT AND IDENTITY THE ROOT CAUSE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION A SUPPLEMENTAL REPORT WILL BE FILED. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD IAG BC PRO DID NOT RETRACT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A FEW COMPLAINTS THAT THE NEEDLE WON'T RETRACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637999 BD IAG BC PRO PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3222379 00382903925230

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown