BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8179386 · Received December 19, 2018

    Report

    Report Number
    1710034-2018-00926
    Event Type
    Malfunction
    Date Received
    December 19, 2018
    Date of Event
    December 3, 2018
    Report Date
    January 31, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835196
    PMA / PMN Number
    K161777
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED WITH THE USE OF THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM THERE WAS AN ISSUE WITH TUBING SEPARATING ON 2 OCCURRENCES. DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. INVESTIGATION SUMMARY: RECEIVED AN 18GA NEXIVA CATHETER-ADAPTER ASSEMBLY. THE REMAINDER OF THE UNIT (EXT. SET, NEEDLE ASSEMBLY & PACKAGING) WAS NOT RETURNED FOR EVALUATION. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF SEPARATION ADAPTER FROM TUBING WITH LOT #8232654 REGARDING ITEM #383519. DHR REVIEW SHOWS THE LOT NUMBER WAS BUILT / PACKAGE ON NFA LINE 1 FROM 23AUG2018 THRU 26AUG2018 FOR THE AMOUNT OF (B)(4). 1 NON-RELATED QUALITY NOTIFICATION WAS INITIATED DURING PRODUCTION. ALL OTHER CHALLENGE, SET UP AND IN-PROCESS SAMPLES WERE PERFORMED AND PASSED PER SPECIFICATIONS. INVESTIGATION CONCLUSION: TRACES OF PATIENT RESIDUE WAS OBSERVED THROUGHOUT THE COMPONENTS OF THE CATHETER-ADAPTER ASSEMBLY RECEIVED. THE EXTENSION TUBING WAS MISSING FROM THE PORT OF THE WINGED ADAPTER. TRACES OF ADHESIVE RESIDUE WERE PRESENT ON THE OUTER RIM OF THE WING ADAPTER PORT. ROOT CAUSE DESCRIPTION: 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 26 SEP 2018 TO BETTER PROTECT THE TIPS FROM DAMAGE AND BECOMING MISALIGNED. RATIONALE: CAPA 684099 HAS BEEN INITIATED TO FURTHER INVESTIGATE THIS ISSUE. REVIEW OF THE END USER RISK ANALYSIS (EURA) DISCLOSED THAT WITH LIMITED SEVERITY AND OCCASIONAL OCCURRENCE, THE RISK TO THE END USER IS ACCEPTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM THERE WAS AN ISSUE WITH TUBING SEPARATING ON 2 OCCURRENCES. DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 WITH THE USE OF THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM THERE WAS AN ISSUE WITH TUBING SEPARATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017163 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8232654 30382903835196

    Patients

    Seq Age Sex Outcome Treatment
    1 Other