BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ NEXIVAS

    MDR report key: 8236975 · Received January 10, 2019

    Report

    Report Number
    1710034-2018-00997
    Event Type
    Malfunction
    Date Received
    January 10, 2019
    Date of Event
    December 1, 2018
    Report Date
    February 15, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835196
    PMA / PMN Number
    K102520
    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: DHR REVIEW FOR LOT 8232354 DISCLOSED THE FOLLOWING: *LOT NUMBER WAS BUILT / PACKAGED ON NFA LINE 1 FROM 23AUG2018 THRU 26AUG2018 FOR THE AMOUNT OF 235,210EA. *ALL CHALLENGE, SET UP AND IN-PROCESS SAMPLES WERE PERFORMED PER SPECIFICATIONS. THERE WERE NO REJECT ACTIVITY FINDINGS RELEVANT TO THE REPORTED DEFECT ASSOCIATED WITH THE LOT NUMBER PROVIDED FOR THIS INCIDENT AS THERE WAS ONLY ONE NON-RELATED IP QN INITIATED FOR THIS LOT. ONE PHOTO WAS PROVIDED FOR EVALUATION OF THIS INCIDENT. PHOTO WAS OF A REPRESENTATIVE UNIT, WHICH CONSISTED OF THE CATHETER/ADAPTER AND EXTENSION LINE ASSEMBLIES. THERE WAS ALSO A TOP WEB OF A PACKAGE FROM AN 18GA BD NEXIVA CLOSED IV CATHETER SYSTEM S/P FROM LOT 8232654. ALTHOUGH THE PHOTO DID NOT REVEAL THE ACTUAL DEFECT; THERE IS WRITING ¿BREAKING POINT¿ AND AN ARROW POINTING TO THE LOCATION WHERE THE EXTENSION TUBING IS ADHERED WITHIN THE CLEAR PORT OF THE WINGED ADAPTER (STABILIZATION PLATFORM). *THE PHOTO DOES NOT PROVIDE SUFFICIENT EVIDENCE TO IDENTIFY THE DEFECT OR TO ESTABLISH A ROOT CAUSE. CONCLUSION: THE DEFECT WAS NOT CONFIRMED AND A DEFINITE ROOT CAUSE COULD NOT BE IDENTIFIED FOR THIS INCIDENT SINCE NO SAMPLE WAS RETURNED. * HOWEVER, THE DEFECT DESCRIBED IN THE PHOTO IS A KNOWN ISSUE AND THE MOST LIKELY ROOT CAUSE WAS THE MANUFACTURING PROCESS. MANUFACTURING ¿ *THE DEFECT IDENTIFIED IN THIS INCIDENT WAS CREATED AT THE ZONE 8 ADHESIVE DISPENSE STATION AFTER THE STATION REDESIGN. IF AIR GOT IN THE LINES THAT FED ADHESIVE TO THE ADHESIVE DISPENSE GRIPPERS, A SHORT SHOT OF ADHESIVE WOULD BE DISPENSED ONTO THE TUBE. A NEW STATION DESIGN WAS INSTALLED ON NFA1 ZONE 8 IN APRIL 2018 (PROTOCOL 18449) THAT THE EXTENSION TUBE ADHESIVE DISPENSE STATIONS ARE PURGED ON A REGULAR BASIS AND CURRENT PROCESS CONTROLS INCLUDE ROUTINE LEAK TEST AND EXT. PULL TEST WELL AS A 100% ONLINE FLOW TESTER IN ZONE 8. CAPA 684099 WAS OPENED TO INVESTIGATE THE SEPARATION ADAPTER FROM TUBING COMPLAINTS AND IMPLEMENT CORRECTIVE ACTIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD¿ NEXIVAS WAS BROKEN DURING USE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD NEXIVAS WAS BROKEN DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27001 BD¿ NEXIVAS PERIPHERAL VASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8232654 30382903835196

    Patients

    Seq Age Sex Outcome Treatment
    1 Other