BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 15217075 · Received August 12, 2022

    Report

    Report Number
    9610847-2022-00300
    Event Type
    Malfunction
    Date Received
    August 12, 2022
    Date of Event
    July 15, 2022
    Report Date
    October 18, 2022
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    30382903835325
    PMA / PMN Number
    K173354
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1193064. MEDICAL DEVICE EXPIRATION DATE: 30-JUN-2024. DEVICE MANUFACTURE DATE: 12-JUL-2021.

    Additional Manufacturer Narrative · 0

    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 LOTS, 1193064 AND 1202525, AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER REVIEWED THE PROVIDED PHOTO AND OBSERVED THAT THE NEEDLE AND WHITE FINGER GRIPS HAD BEEN RETRACTED BUT THE GRAY TIP SHIELD REMAINED ATTACHED TO THE CATHETER ADAPTER. THEREFORE, BASED OFF THE PROVIDED PHOTO THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. UNFORTUNATELY, WITHOUT A PHYSICAL SAMPLE AVAILABLE FOR INSPECTION A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM EXPERIENCED THE SAFETY STYLET WOULD NOT REMOVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING CANNULATION WITH NEXIVA 22 GA, THE SAFETY STYLET DID NOT COME OUT FROM THE HUB.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM EXPERIENCED THE SAFETY STYLET WOULD NOT REMOVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING CANNULATION WITH NEXIVA 22 GA, THE SAFETY STYLET DID NOT COME OUT FROM THE HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1994791 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 383532 1202525 30382903835325

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown