BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA SINGLE PORT

    MDR report key: 20140730 · Received September 4, 2024

    Report

    Report Number
    1710034-2024-00978
    Event Type
    Malfunction
    Date Received
    September 4, 2024
    Date of Event
    June 14, 2024
    Report Date
    September 4, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835171
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT OF A DAMAGED CATHETER TIP WAS CONFIRMED FROM THE TWO PHOTOGRAPHS AND PHYSICAL SAMPLE THAT WERE PROVIDED FOR INVESTIGATION; HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF CATHETER TIP INTEGRITY WITH LOT # 3234046 REGARDING ITEM # 383517 THE DHR FOR LOT 3234046 WAS REVIEWED. THIS LOT WAS BUILT AND PACKAGED ON NFA LINE 1 FROM 02-SEP-2024 THROUGH 06-SEP-2024 FOR A QUANTITY OF (B)(4). NO RELATED QUALITY ISSUES OR PROCESS DEVIATIONS WERE FOUND. THE CATHETER TIP WAS UNEVEN DUE TO THE NEEDLE PUNCTURING THE TUBING. DUE TO THE EVIDENCE OF USE, THE REPORTED DAMAGE MAY HAVE OCCURRED DURING THE INSERTION PROCESS. A NEEDLE PERFORATING THROUGH THE CATHETER MAY OCCUR IN THE CLINICIAN SETTING DURING VENIPUNCTURE IF THE NEEDLE IS ADVANCED AT A WRONG ANGLE OR IF THE NEEDLE IS MOVED UP AND DOWN THE CATHETER TUBING WHILE THE TUBING IS IN THE VEIN; HOWEVER, AS IT WAS REPORTED THAT THE CLINICIAN WAS UNABLE TO DELIVER THE CATHETER PROPERLY, IT IS POSSIBLE THAT THE DAMAGE WAS NOT DETECTED UNTIL AFTER AN ATTEMPT WAS MADE TO INSERT THE NEEDLE. AS THE DEVICE HAS BEEN OPENED AND USED, IT COULD NOT BE DETERMINED WITH CERTAINTY WHETHER THE DAMAGE ORIGINATED DURING MANUFACTURING OR USE OF THE DEVICE. MANUFACTURING CONTROLS ARE IN PLACE TO MITIGATE THE OCCURRENCE OF THIS TYPE OF FAILURE. THE COMPLAINT HAS BEEN DOCUMENTED AND WILL CONTINUE TO BE MONITORED AS PART OF ONGOING EFFORTS TO IDENTIFY POTENTIAL MANUFACTURING RELATED ISSUES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA SINGLE PORT NEEDLE PIERCED THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: RADIOLOGY PUNCTURE OF 20G NEXIVA, SUCCESSFUL PUNCTURE WITH GOOD BLOOD RETURN, BUT UNABLE TO DELIVER THE CATHETER PROPERLY, THREE ATTEMPTS COULD NOT BE DELIVERED, AND AFTER REMOVAL OF THE CATHETER, A BURR ABNORMALITY WAS FOUND AT THE TIP OF THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104672 BD NEXIVA SINGLE PORT PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3234046 00382903835171

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown