BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM WITH DUAL PORT

    MDR report key: 7948389 · Received October 9, 2018

    Report

    Report Number
    1710034-2018-00695
    Event Type
    Malfunction
    Date Received
    October 9, 2018
    Date of Event
    September 10, 2018
    Report Date
    October 31, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835363
    PMA / PMN Number
    K161777
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED A 20GA CATHETER-ADAPTER ASSEMBLY EXTENSION SET ALONG WITH A PIECE OF TOP WEB (PACKAGING) FROM LOT NUMBER 8121733. THE UNIT WAS HEAVILY SOILED WITH PATIENT RESIDUE (BLOOD). THE EXTENSION SET WAS RECEIVED IN 2 PORTIONS: THE Y ADAPTER WITH THE EXTENSION TUBING WAS SEPARATED FROM THE PORT OF THE WING ADAPTER. NO TRACES OF ADHESIVE WERE FOUND ON THE EXTENSION TUBING OR THE ADAPTER PORT. DHR- THE LOT NUMBER WAS BUILT/PACKAGED ON NFA LINE #1 FROM (B)(6) 2018 THRU (B)(6) 2018. REVIEW DISCLOSED ONE NON-RELATED QN (200760384-ILLEGIBLE PRINT) WAS INITIATED DURING BUILD OF THIS LOT. DISPOSITION, ROOT CAUSE AND CORRECTIVE ACTION WERE APPLIED PER QUALITY CONTROL PLAN. ALL OTHER REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WERE PERFORMED AND PASSED PER SPECIFICATIONS. CONCLUSION(S): MANUFACTURING- THE DEFECT OBSERVED 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA CLOSED IV CATHETER SYSTEM WITH DUAL PORT DETACHED DURING USE. 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 WITH DUAL PORT DETACHED DURING USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786985 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM WITH DUAL PORT INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8187553 30382903835363

    Patients

    Seq Age Sex Outcome Treatment
    1 Other