BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8947046 · Received August 29, 2019

    Report

    Report Number
    1710034-2019-00948
    Event Type
    Malfunction
    Date Received
    August 29, 2019
    Date of Event
    August 1, 2019
    Report Date
    August 29, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835127
    PMA / PMN Number
    K183399
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE DEFECT ASPIRATE/DRAW (CANNOT/DIFFICULT); COULD NOT BE IDENTIFIED OR CONFIRMED, AND CAUSE COULD NOT BE DETERMINED, AS THE UNITS DESCRIBED IN THE PRODUCT INCIDENT REPORT WERE NOT RETURNED FOR EVALUATION AND TESTING. A COMPLAINT HISTORY CHECK WAS PERFORMED, AND THIS IS THE 4TH RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF ASPIRATE/DRAW (CANNOT/DIFFICULT) WITH LOT #9137627 REGARDING ITEM #383512. OCCURRENCE: 5TH. RELATED COMPLAINTS: (B)(4). INVESTIGATION CONCLUSION: THE DEFECT ASPIRATE/DRAW (CANNOT/DIFFICULT); COULD NOT BE IDENTIFIED OR CONFIRMED, AND CAUSE COULD NOT BE DETERMINED, AS THE UNITS DESCRIBED IN THE PRODUCT INCIDENT REPORT WERE NOT RETURNED FOR EVALUATION AND TESTING. ROOT CAUSE DESCRIPTION: WITHOUT THE ACTUAL SAMPLE FOR EVALUATION AND TESTING THERE WAS NO PHYSICAL EVIDENCE TO CONFIRM OR SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE REPORTED DEFECT. THEREFORE; THE ROOT CAUSE WAS INDETERMINATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ASPIRATION ISSUES OCCURRED DURING USE WITH A BD NEXIVA¿ CLOSED IV CATHETER SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "(B)(6) 2019 AT 0832: 22 GAUGE X 1 INCH BD NEXIVA IV CATHETER WITH LOT NUMBER 9137627 NOT WORKING PROPERLY. CATHETER WAS IN THE VEIN AND WOULD NOT DRAW BLOOD/ OR DREW VERY SLOW TO HEMOLYZE SPECIMEN. BLUE NEEDLESS TRANSFER DEVICE NOR SYRINGE DID NOT WORK TO DRAW BLOOD/ OR DREW VERY SLOW TO LEAD TO HEMOLYSIS AND PATIENT BEING STUCK ADDITIONAL TIMES FOR BLOOD. IV CATHETER FLUSHED WITHOUT PROBLEMS. CATHETER WAS DISCARDED AFTER BEING REMOVED FROM PATIENT. THIS EVENT REQUIRED ADULT PATIENT TO BE STUCK AN ADDITIONAL TIME FOR IV PLACEMENT AND BLOOD DRAW. EXPIRATION DATE: 2022-04-30. ITEM: 22 GA 1.00 IN BD NEXIVA CATHETER. LOT #: 9137627. REFERENCE #: (B)(4). 1 OF 5 COMPLAINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742061 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9137627 30382903835127

    Patients

    Seq Age Sex Outcome Treatment
    1 Other