BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA CLOSED IV CATHETER SYSTEM

    MDR report key: 11143938 · Received January 9, 2021

    Report

    Report Number
    1710034-2021-00016
    Event Type
    Malfunction
    Date Received
    January 9, 2021
    Date of Event
    December 14, 2020
    Report Date
    April 29, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835127
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD RECEIVED ONE OPENED UNRETRACTED 22 GAUGE NEXIVA UNIT FROM LOT 0052669 FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNIT FOR SIGNS OF BLACK FOREIGN MATTER (FM) BUT COULD NOT IDENTIFY ANY PIECES OF FOREIGN MATTER PRESENT INSIDE THE PACKAGING OR ON THE UNIT. HOWEVER, BASED OFF THE PROVIDED PHOTOS THE ENGINEER WAS ABLE TO IDENTIFY BLACK FM ON THE CATHETER TUBING BUT COULD NOT DETERMINE WHAT THE FM WAS OR ITS ORIGIN. BASED OFF THE PROVIDED PHOTO THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. UNFORTUNATELY, SINCE THERE WAS NO FM FOUND DURING INSPECTION THE ENGINEER COULD NOT COLLECT THE FM FOR TESTING TO DETERMINE WHAT THE FM WAS. WITHOUT KNOWING WHAT THE FM WAS A ROOT CAUSE OR ORIGIN COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BLACK FOREIGN MATTER WAS FOUND IN THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM TUBE AFTER OPENING THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "AFTER OPENED THE PACKAGE, THE BLACK FOREIGN MATTER WAS FOUND IN THE CATHETER TUBE."

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLACK FOREIGN MATTER WAS FOUND IN THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM TUBE AFTER OPENING THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "AFTER OPENED THE PACKAGE, THE BLACK FOREIGN MATTER WAS FOUND IN THE CATHETER TUBE"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40015 BD NEXIVA CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 383512 0052669 30382903835127

    Patients

    Seq Age Sex Outcome Treatment
    1