BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA

    MDR report key: 19397621 · Received May 24, 2024

    Report

    Report Number
    1710034-2024-00494
    Event Type
    Malfunction
    Date Received
    May 24, 2024
    Date of Event
    May 1, 2024
    Report Date
    May 7, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835362
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER (B)(4) AND LOT NUMBER 4030906. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH NEEDLE DISENGAGEMENT DIFFICULT WITH LOT # 4030906 REGARDING ITEM 383536. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA NEEDLE DISENGAGEMENT DIFFICULT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE GRAY AND WHITE PIECE OF THE CATHETER WORKS AS IT SHOULD. NO TROUBLE ADVANCING THE CATHETER INTO THE VEIN. IT IS WHEN THE CATHETER IS PLACED AND YOU WANT TO REMOVE THE NEEDLE FROM THE HUB THAT THE ISSUE OCCURS. THE GRAY PIECE DOES NOT WANT TO SEPARATE FROM THE CATHETER HUB. I KNOW OF THREE ISSUES THAT WE HAVE HAD. IT DID NOT INVOLVE URGENT/LIFE THREATING MEDICAL SITUATION. I THINK WHEN WE SPOKE THE OTHER DAY WE MAY HAVE HAD A MISUNDERSTANDING OF THE ISSUE. THE STAFF ARE USING PROPER PROCEDURE TO ACCESS THE VEIN. ONCE THEY ACCESS THEY ADVANCE THE CATHETER UNTIL THE NEEDLE IS COMPLETELY RETRACTED. THIS OCCURS WITHOUT ISSUE. THE ISSUE IS WHEN THEY GO TO SEPARATE THE NEEDLE FROM THE CATHETER GRAY PIECE TO HUB IT DOES NOT WANT TO SEPARATE FROM THE CATHETER. THE RISK IS PULLING THE CATHETER OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643842 BD NEXIVA PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4030906 00382903835362

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown