BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 9384012 · Received November 27, 2019

    Report

    Report Number
    1710034-2019-01268
    Event Type
    Malfunction
    Date Received
    November 27, 2019
    Date of Event
    October 30, 2019
    Report Date
    December 27, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835165
    PMA / PMN Number
    K183399
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE SAMPLES PROVIDED. BD RECEIVED TWO 20GA NEXIVA UNITS FROM LOT NUMBER 9182260. ONE OF THE UNITS WAS WITHIN AN OPEN PACKAGE AND THE OTHER WITHIN A SEALED PACKAGE. ALONG WITH THE UNITS, A PIECE OF TOP WEB (PKG) WAS RECEIVED. THROUGH THE VISUAL EXAMINATION OF THE UNITS, DAMAGE WAS NOT OBSERVED ON ANY OF THE COMPONENTS OF BOTH THE UNIT IN THE OPENED PACKAGE AND SEALED PACKAGE. A WATER LEAK TEST WAS ALSO PERFORMED ON BOTH UNITS. LEAKAGE WAS NOT OBSERVED. THE RETURNED REPRESENTATIVE UNITS DID NOT DISPLAY ANY ADVERSE CHARACTERISTICS THAT WOULD CONTRIBUTE TO THE DEFECT YOUR FACILITY EXPERIENCED. THE FAILURE DESCRIBED COULD NOT BE REPLICATED AT THE LABORATORY. THE ACTUAL UNIT WAS NOT RECEIVED FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER PLACEMENT OF THE CATHETER IT WAS DISCOVERED THAT THE TUBING WAS DAMAGED AND LEAKAGE OCCURRED WITH A BD NEXIVA¿ CLOSED IV CATHETER SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RN PLACED THE CATHETER AND STARTED THE FLUIDS. IMMEDIATELY NOTED THE TUBING WAS LEAKING FROM A CREASE WHERE THE TUBING LOOKED LIKE IT HAD BEEN CLAMPED. THE NURSE DID NOT RECALL IF THE TUBING WAS CLAMPED WHEN IT WAS TAKEN FROM THE PACKAGE BECAUSE IT IS STANDARD TO HAVE IT UNCLAMPED WITH INSERTION. THE LOT #S WERE PULLED FROM THE UNIT AND BROUGHT ME. TODAY I LOOKED AT THE TWO PACKAGES AND OPENED ONE. WHEN I OPENED ONE, THE CLAMP WAS CLOSED AND WHEN I OPENED IT THERE WAS A DEEP CREASE. THE SECOND CATHETER WAS UN-CLAMPED IN THE PACKAGE AS IS THE STANDARD. UNFORTUNATELY WE DO NOT HAVE THE CATHETER USED WITH THE PATIENT.

    Additional Manufacturer Narrative · 1

    A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER PLACEMENT OF THE CATHETER IT WAS DISCOVERED THAT THE TUBING WAS DAMAGED AND LEAKAGE OCCURRED WITH A BD NEXIVA¿ CLOSED IV CATHETER SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RN PLACED THE CATHETER AND STARTED THE FLUIDS. IMMEDIATELY NOTED THE TUBING WAS LEAKING FROM A CREASE WHERE THE TUBING LOOKED LIKE IT HAD BEEN CLAMPED. THE NURSE DID NOT RECALL IF THE TUBING WAS CLAMPED WHEN IT WAS TAKEN FROM THE PACKAGE BECAUSE IT IS STANDARD TO HAVE IT UNCLAMPED WITH INSERTION. THE LOT #S WERE PULLED FROM THE UNIT AND BROUGHT ME. TODAY I LOOKED AT THE TWO PACKAGES AND OPENED ONE. WHEN I OPENED ONE, THE CLAMP WAS CLOSED AND WHEN I OPENED IT THERE WAS A DEEP CREASE. THE SECOND CATHETER WAS UN-CLAMPED IN THE PACKAGE AS IS THE STANDARD. UNFORTUNATELY WE DO NOT HAVE THE CATHETER USED WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1182512 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9182260 30382903835165

    Patients

    Seq Age Sex Outcome Treatment
    1 Other