BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 12072224 · Received June 25, 2021

    Report

    Report Number
    1710034-2021-00529
    Event Type
    Malfunction
    Date Received
    June 25, 2021
    Date of Event
    May 28, 2021
    Report Date
    August 16, 2021
    Product Code
    FOZ
    UDI-DI
    30382903835127
    PMA / PMN Number
    K102520
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4: CATALOG # 383532, D4: MEDICAL DEVICE LOT #: 1035216, D4: MEDICAL DEVICE EXPIRATION DATE: 2024-01-31, D4: UDI # (B)(4), G.5. PMA / 510(K)#: K102520, H4: DEVICE MANUFACTURE DATE: 2021-02-04. H6: INVESTIGATION SUMMARY: A PHYSICAL SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION BUT BD WAS PROVIDED WITH A PHOTO OF THE ISSUE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT, 1035216, AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER REVIEWED THE PROVIDED PHOTO AND OBSERVED A NEXIVA DISPENSER BOX WITH A MISSING LABEL. BASED OFF THE PROVIDED PHOTO THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. DISPENSE LABELS ARE EITHER PLACED BY THE PACKAGING OPERATORS OR BY AN AUTOMATED SYSTEM USING A VISION SYSTEM TO DETECT FOR ANY MISSING LABELS. IT WAS DETERMINED THAT THIS WAS AN OPERATOR ERROR. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS INCIDENT AND THE FINDINGS. A NOTIFICATION WAS ISSUED TO ALL PACKAGING OPERATORS TO RAISE AWARENESS OF THIS INCIDENT AND PREVENT RECURRENCE. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 20 BD NEXIVA¿ CLOSED IV CATHETER SYSTEMS HAD NO LABEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PRODUCT LABEL IS MISSING."

    Additional Manufacturer Narrative · 1

    THE REPORTED LOT # 1035216 WAS NOT FOUND FOR THE REPORTED CATALOG # 383512. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 20 BD NEXIVA¿ CLOSED IV CATHETER SYSTEMS HAD NO LABEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PRODUCT LABEL IS MISSING".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968477 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ 383512 1035216 30382903835127

    Patients

    Seq Age Sex Outcome Treatment
    1