BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 9294334 · Received November 8, 2019

    Report

    Report Number
    1710034-2019-01191
    Event Type
    Malfunction
    Date Received
    November 8, 2019
    Date of Event
    October 16, 2019
    Report Date
    November 21, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835127
    PMA / PMN Number
    K183399
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, SO WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THE BATCHES PROVIDED. NO ROOT CAUSE CAN BE DETERMINED. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM THERE WAS AN ISSUE WITH LEAKAGE DUE TO CONNECTION DEFECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: WHEN CONFIRMING FLASH BACK, BLOOD LEAKED. CUSTOMER FOUND CONNECTION DEFECT.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9137627. MEDICAL DEVICE EXPIRATION DATE: 2022-04-30. DEVICE MANUFACTURE DATE: 2019-05-17. MEDICAL DEVICE LOT #: 9130913. MEDICAL DEVICE EXPIRATION DATE: 2022-04-30. DEVICE MANUFACTURE DATE: 2019-05-10. 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 DURING USE OF THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM THERE WAS AN ISSUE WITH LEAKAGE DUE TO CONNECTION DEFECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: WHEN CONFIRMING FLASH BACK, BLOOD LEAKED. CUSTOMER FOUND CONNECTION DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1088653 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR ADMINISTRATION SET FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H.10 30382903835127

    Patients

    Seq Age Sex Outcome Treatment
    1 Other