BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8302316 · Received February 4, 2019

    Report

    Report Number
    1710034-2019-00137
    Event Type
    Malfunction
    Date Received
    February 4, 2019
    Date of Event
    January 16, 2019
    Report Date
    April 2, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835318
    PMA / PMN Number
    K161777
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: DHR FOR LOT 8243975 REVEALED THE FOLLOWING: A TOTAL OF (B)(4) WERE MANUFACTURED ON NFA LINE 2 FROM 4SEP18 THROUGH 11SEP2018 NO OTHER SIGNIFICANT FINDINGS WERE OBSERVED. ALTHOUGH SAMPLES WERE NOT RECEIVED, A PHOTO WAS PROVIDED FOR OBSERVATION OF THIS REPORTED INCIDENT. VISUAL/MICROSCOPIC EVALUATION: THE DEFECT OF DECOUPLING ISSUES WAS CONFIRMED BASED ON THE OBSERVATIONS OF THE PHOTO PROVIDED FOR THIS INCIDENT, WHICH RESULTED IN NEEDLE SHIELDING FAILURE. CONFIRMED THE UNIT IN THE PHOTO SHOWN INDICATIONS OF HAVING DECOUPLED PRIOR TO THE NEEDLE BEING PULLED BACK INTO THE TIP SHIELD. ANOMALIES OR DAMAGE TO ANY OF THE COMPONENTS WHICH COULD RESULT IN HINDERING THE UNIT FROM DISENGAGING AND/OR DECOUPLING PROPERLY COULD NOT BE CONFIRMED AS THE PHOTO DID NOT PROVIDE SUFFICIENT EVIDENCE. CONCLUSION(S): RELATIONSHIP OF DEVICE TO THE REPORTED INCIDENT: MANUFACTURING. CONFIRMATION OF THE REPORTED DEFECT OF NEEDLE SHIELDING FAILURE WAS CONCLUSIVE BASED ON THE FINDINGS OF DECOUPLING ISSUES OBSERVED IN THE PHOTO PROVIDED FOR THIS INCIDENT. ALTHOUGH THE ROOT CAUSE IS MANUFACTURING RELATED; WITHOUT THE ACTUAL AFFECTED UNIT FOR OBSERVATIONS AND/OR TESTING A DEFINITE SOURCE COULD NOT BE DETERMINED, AS THE PHOTO DID NOT PROVIDED SUFFICIENT EVIDENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SAFETY SHIELD DEVICE ON THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM FAILED TO COVER THE NEEDLE "AS THE WHITE AND GREY PART SEPARATE".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). OTHER OCCUPATION: PROFESSIONAL LEAD QUALITY GOVERNANCE & STANDARDS ¿ SPECIAL CARE DENTAL SERVICE. 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 THE SAFETY SHIELD DEVICE ON THE BD NEXIVA CLOSED IV CATHETER SYSTEM FAILED TO COVER THE NEEDLE "AS THE WHITE AND GREY PART SEPARATE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95626 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8243975 30382903835318

    Patients

    Seq Age Sex Outcome Treatment
    1 Other