BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA 20GA 1.25IN HF Y

    MDR report key: 11370289 · Received February 24, 2021

    Report

    Report Number
    1710034-2021-00140
    Event Type
    Malfunction
    Date Received
    February 24, 2021
    Date of Event
    January 28, 2021
    Report Date
    March 29, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835379
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 2/16/2021. H.6. INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE SAMPLES AND PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED ELEVEN UNOPENED UNITS AND SEVEN PHOTOS. DURING THE VISUAL EXAMINATION OF THE UNITS AND PHOTOS, IT WAS OBSERVED THAT EXCESS MATERIAL AND SHARP EDGES WERE PRESENT CONFIRMING THE REPORTED DEFECT. MISALIGNMENT OR INCORRECT SETUP DURING THE CUTTING PROCESS MAY RESULT IN EXCESS MATERIAL LIKE THAT OBSERVED IN THE RETURNED UNITS RESULTING IN SHARP EDGES; THEREFORE, THE MOST PROBABLE ROOT CAUSE IS MANUFACTURING. THE SEAL WIDTH WAS MEASURED TO DETERMINE IF A SUFFICIENT SEAL WAS MADE. ALL ELEVEN SEALS WERE FOUND TO BE WITHIN SPECIFICATION INDICATING THAT THE STERILITY WAS NOT AFFECTED BY THE DEFECT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEXIVA 20GA 1.25IN HF Y PACKAGE WAS DAMAGED. THIS OCCURRED ON 11 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT DAMAGED PACKAGES. ACCORDING TO THE CUSTOMER'S REPORT, THE PACKAGE COMPONENT (PLASTIC TRAY) WAS DAMAGED (DEFORMED) IN 11 OF 20 PRODUCTS. (ADDITIONAL INFORMATION ON 02/03/2021) THE PERIPHERY OF THE PACKAGE TRAY WAS PARTLY DEFORMED SHARPLY (UPPER PART) OR CUT DIAGONALLY (LOWER PART) AND THE CUSTOMER IS QUESTIONING WHETHER STERILIZATION OF THE PACKAGE HAS BEEN GUARANTEED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEXIVA 20GA 1.25IN HF Y PACKAGE WAS DAMAGED. THIS OCCURRED ON 11 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT DAMAGED PACKAGES. ACCORDING TO THE CUSTOMER'S REPORT, THE PACKAGE COMPONENT (PLASTIC TRAY) WAS DAMAGED (DEFORMED) IN 11 OF 20 PRODUCTS. (ADDITIONAL INFORMATION ON 02/03/2021). THE PERIPHERY OF THE PACKAGE TRAY WAS PARTLY DEFORMED SHARPLY (UPPER PART) OR CUT DIAGONALLY (LOWER PART) AND THE CUSTOMER IS QUESTIONING WHETHER STERILIZATION OF THE PACKAGE HAS BEEN GUARANTEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272334 NEXIVA 20GA 1.25IN HF Y INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 0168884 00382903835379

    Patients

    Seq Age Sex Outcome Treatment
    1