BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8061151 · Received November 12, 2018

    Report

    Report Number
    1710034-2018-00834
    Event Type
    Malfunction
    Date Received
    November 12, 2018
    Date of Event
    October 22, 2018
    Report Date
    December 20, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835370
    PMA / PMN Number
    K161777
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: RECEIVED A 20GA NEXIVA CATHETER-ADAPTER EXTENSION SET WITHIN AN OPEN PACKAGE FROM LOT NUMBER 8172681. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF SEPARATION INSERTER FROM TUBING WITH LOT #8172681 REGARDING ITEM #383537. DHR REVIEW: THE LOT WAS BUILT / PACKAGED ON NFA LINE #1 FROM 26JUN2018 THROUGH 29JUN2018 FOR THE QUANTITY OF (B)(4) EA. REVIEW OF DHR REVEALED ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. THERE WERE 6 TEMPORARY DEVIATIONS IN AFFECT DURING THE BUILD OF THIS LOT, OF WHICH NONE WERE RELEVANT TO THE REPORTED DEFECT: ((B)(4)). NO QUALITY NOTIFICATION WERE INITIATED DURING THE BUILD OF THIS LOT NUMBER. TRACES OF PATIENT RESIDUE WAS OBSERVED THROUGHOUT THE COMPONENTS OF THE UNITS RECEIVED. THE EXTENSION TUBING WAS NOT INSERTED (ATTACHED) TO THE PORT OF THE WINGED ADAPTER. NO TRACE OF ADHESIVE WAS OBSERVED ON THE TUBING. TRACES OF ADHESIVE RESIDUE WERE PRESENT ON THE OUTER RIM OF THE WING ADAPTER PORT. COMPLAINT TREND RESULTED IN INITIATION OF CAPA 684099. THE MANUFACTURING DEPARTMENT IDENTIFIED THE ISSUE AND TOOK IMMEDIATE CORRECTIVE ACTION ON 11 SEP 2018 BY UPGRADING THE VISION SYSTEM ON BOTH PRODUCTION LINES TO BE ABLE TO DETECT ADHESIVE THAT WAS NOT IN THE CORRECT LOCATION. HOLDERS FOR THE ADHESIVE DISPENSE TIPS WERE ADDED TO THE MACHINE ON (B)(6)2018 TO BETTER PROTECT THE TIPS FROM DAMAGE AND BECOMING MISALIGNED. EURA (END USER RISK ANALYSIS) REVIEW: BASED ON THE INFORMATION PROVIDED, THE EFFECT OF THE DEVICE FAILURE WAS LEAKAGE THAT DID NOT REQUIRE MEDICAL INTERVENTION. RM5796 REV 16(O) NEXIVA P-EURA IDENTIFIES THE FAILURE MODE OF EXTENSION TUBING DETACHED FROM THE CATHETER ADAPTER WITH CAUSE OF FAILURE BEING INSUFFICIENT ADHESIVE, AND IT STATES THAT THE EFFECT OF MINOR LEAKAGE HAS A LIMITED SEVERITY WITH RANKING S2. THE END USER EFFECT OF MINOR LEAKAGE HAS OCCASIONAL OCCURRENCE OF O3 ( =100 IPM) FOR THE FAILURE MODE OF EXTENSION TUBING DETACHED FROM CATHETER ADAPTER. WITH LIMITED SEVERITY AND OCCASIONAL OCCURRENCE, THE RISK TO THE END USER IS ACCEPTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA¿ CLOSED IV CATHETER SYSTEM EXHIBITED TUBING SEPARATION AND LEAKED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD NEXIVA¿ CLOSED IV CATHETER SYSTEM EXHIBITED TUBING SEPARATION AND LEAKED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901729 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8172681 30382903835370

    Patients

    Seq Age Sex Outcome Treatment
    1 Other