BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM W/ DUAL PORT

    MDR report key: 7837299 · Received August 31, 2018

    Report

    Report Number
    1710034-2018-00599
    Event Type
    Malfunction
    Date Received
    August 31, 2018
    Date of Event
    August 9, 2018
    Report Date
    November 20, 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

    INVESTIGATION SUMMARY: THE LOT WAS BUILT ON NFA LINE 1 FROM 3MAY2018 THROUGH 7MAY2018 FOR THE AMOUNT OF 268,810EA. (B)(4) FOR ¿EXT TUBE ADHESIVE OOS¿ COULD BE POTENTIALLY RELATED TO THIS INCIDENT. DISPOSITION, ROOT CAUSE AND CORRECTIVE ACTIONS FOR THE QUALITY NOTIFICATION ARE CURRENTLY IN PROCESS. TD 2018-23 (ADHESIVE DEEP CLEANING) AND TD 2018-29 (ADHESIVE VALVES PURGE) WERE IN PLACED DURING THE PRODUCTION OF THE LOT # RELATED TO THIS INVESTIGATION. ALL OTHER CHALLENGE, SET UP AND CORRECTIVE ACTIONS WERE PERFORMED ACCORDING TO THE QUALITY CONTROL PLAN AND ALL PASSED PER SPECIFICATIONS. RECEIVED A 20GA CATHETER-ADAPTER ASSEMBLY EXTENSION SET WITHIN AN OPEN PACKAGE FROM LOT NUMBER: 8121733. THE UNIT WAS HEAVILY SOILED WITH PATIENT RESIDUE (BLOOD). THE EXTENSION SET WAS RECEIVED IN 2 PORTIONS: THE CATHETER-ADAPTER ASSEMBLY (WINGED ADAPTER) WAS SEPARATED FROM THE PORT ADAPTER WITH THE EXTENSION TUBING. NO TRACES OF ADHESIVE WERE FOUND ON THE EXTENSION TUBING OR THE ADAPTER PORT. CONCLUSION(S): THIS DEFECT IS CREATED AT THE ZONE 8 ADHESIVE DISPENSE STATION IF AIR GETS IN THE LINES THAT FEED ADHESIVE TO THE ADHESIVE DISPENSE GRIPPERS, CAUSING A SHORT SHOT OF ADHESIVE TO BE DISPENSED ONTO THE TUBE. 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. THE FOLLOWING CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED: VISION UPGRADES TO BETTER DETECT THE NEW FAILURE MODES FROM THE STATION REDESIGN, SEP 11, 2018. DESIGN AND INSTALL TOOLING TO MAKE THE STATION (ADHESIVE DISPENSE TIPS) MORE ROBUST, OCT 17, 2018.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA¿ CLOSED IV CATHETER SYSTEM W/ DUAL PORT ARE DISCONNECTING AT THE HUB OF THE IV CATHETER AND TUBING. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    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 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM W/ DUAL PORT ARE DISCONNECTING AT THE HUB OF THE IV CATHETER AND TUBING. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680932 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM W/ DUAL PORT INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8121733 30382903835363

    Patients

    Seq Age Sex Outcome Treatment
    1 Other