BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA CLOSED IV CATHETER SYSTEM W/ DUAL PORT

    MDR report key: 7735242 · Received July 31, 2018

    Report

    Report Number
    1710034-2018-00478
    Event Type
    Malfunction
    Date Received
    July 31, 2018
    Date of Event
    July 10, 2018
    Report Date
    August 27, 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

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO AN IT ISSUE BEGINNING ON (B)(6) 2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE? NO. DEVICE RETURNED TO MANUFACTURE: YES. INVESTIGATION SUMMARY: RECEIVED A 20GA NEXIVA UNIT WITHIN AN OPEN PACKAGE FROM LOT NUMBER: 8031857. THE NEEDLE-SHIELD ASSEMBLY WAS FULLY DISENGAGED. DHR REVIEW FOR LOT #: 8031857: A TOTAL OF (B)(4) WERE MANUFACTURED ON NEXIVA LINE 1 STARTING ON 2FEB18 THROUGH 10FEB18. ALL CHALLENGES, SET-UP AND IN PROCESS SAMPLES WERE PERFORMED PER QUALITY CONTROL PLAN. FOUND 4 NON-RELATED QN¿S WHERE DISPOSITION OF THE PRODUCT, ROOT CAUSE AND CORRECTIVE ACTIONS WERE APPLIED ACCORDING TO THE QUALITY CONTROL PLAN. 200732637 (DAMAGED SEPTUM) 200739252 (WRONG TIPPING DIE), 200731792 (RUNNING UNDER RISK-NIKON DOWN), 200315587 (INCOMPLETE SEAL), ALL OTHER INSPECTIONS PASSED PER SPECIFICATIONS. VISUAL EVALUATION OF THE UNIT REVEALED THE END OF THE EXTENSION TUBE WAS NOT CORRECTLY INSERTED INTO THE WINGED ADAPTER AND WAS INSTEAD GLUED TO THE TOP PART OF THE PORT. THIS CONDITION WOULD CAUSE LEAKAGE AS EXPERIENCED BY THE CUSTOMER. THIS DEFECT OCCURS DURING THE MANUFACTURING PROCESS ON ZONE 8 AT THE ADHESIVE DISPENSE STATION IF THE CATHETER ADAPTER OR EXTENSION TUBING IS MISALIGNED DURING THE INSERTION PROCESS. CURRENT PROCESS CONTROLS INCLUDE ROUTINE LEAK TESTING AFTER ZONE 9 AS WELL AS A 100% ONLINE FLOW TESTER IN ZONE 8 THE CAUSE OF FAILURE AND FAILURE MODE HAVE BEEN IDENTIFIED IN RM5796 REV 16(O) NEXIVA P-EURA. PER RM5796, THE EFFECT OF MINOR LEAKAGE HAS A LIMITED SEVERITY WITH RANKING S2 WITH FREQUENT OCCURRENCE RATE OF >1000 IPM. WITH LIMITED SEVERITY AND FREQUENT OCCURRENCE, THE RISK TO THE END USER IS UNACCEPTABLE. HOWEVER, RISK TO THE END USER HAS BEEN MITIGATED AS MUCH AS POSSIBLE, AND PER RISK BENEFIT ANALYSIS RBA-1, THE BENEFIT OF GAINING ACCESS TO THE VASCULATURE OUTWEIGHS THE ASSIGNED RISKS. THE OCCURRENCE OF THIS DEFECT FOR BATCH 8031857 IS REMOTE (=10 IPM).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA¿ CLOSED IV CATHETER SYSTEM W/ DUAL PORT HAD A BROKEN CATHETER. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. 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 HAD A BROKEN CATHETER. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578170 BD NEXIVA CLOSED IV CATHETER SYSTEM W/ DUAL PORT BD NEXIVA¿ CLOSED IV CATHETER SYSTEM W/ DUAL PORT FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8031857 30382903835363

    Patients

    Seq Age Sex Outcome Treatment
    1 Other