BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 20GA 1.00IN HF Y

    MDR report key: 19587585 · Received June 21, 2024

    Report

    Report Number
    1710034-2024-00631
    Event Type
    Malfunction
    Date Received
    June 21, 2024
    Date of Event
    May 15, 2024
    Report Date
    July 15, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835362
    PMA / PMN Number
    1
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 5TH RELATED COMPLAINT REPORTED WITH NEEDLE DISENGAGEMENT DIFFICULT WITH LOT # 4030906 REGARDING ITEM 383536. DHR FOR LOT NUMBER 4030906 HAS BEEN REVIEWED. THIS LOT WAS BUILT AND PACKAGED ON NFA LINE 1 FROM 21FEB2024 THROUGH 24FEB2024 FOR A TOTAL QUANTITY OF (B)(4) UNITS. NO RELATED QUALITY ISSUES OR PROCESS DEVIATIONS WERE FOUND. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED.

    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

    NONE ADDITIONAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD 20GA 1.00IN HF Y NEEDLE WAS DIFFICULT TO DISENGAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I KNOW GREG SPOKE WITH YOU REGARDING A RECURRING ISSUE DIFFICULT CATHETER DETACHMENT. WE HAVE SINCE EXPERIENCED ADDITIONAL INSTANCES OF ISSUES WITH FAILED NEEDLE DETACHMENT. 7JUN: ¿ ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? NO. ¿ PLEASE EXPLAIN BRIEFLY PRODUCT DAMAGE. RN WAS UNABLE TO DETACH THE NEEDLE FROM THE IV CATHETER AFTER INSERTION OF THE IV. MULTIPLE STAFF TRIED BEFORE THEY WERE ABLE TO SUCCESSFULLY DETACH THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1183090 BD 20GA 1.00IN HF Y PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4030906 00382903835362

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown