BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    22 G X 1 IN. BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 6071106 · Received November 1, 2016

    Report

    Report Number
    9610847-2016-00041
    Event Type
    Malfunction
    Date Received
    November 1, 2016
    Date of Event
    September 6, 2016
    Report Date
    January 17, 2017
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    PMA / PMN Number
    K123734
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ON 01/03/2017 A SAMPLE WAS RECEIVED FOR EVALUATION AND A LOT NUMBER WAS PROVIDED. THE INFORMATION FOR THE LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6153743, MEDICAL DEVICE EXPIRATION DATE: 06/30/2019, DEVICE MANUFACTURE DATE: 06/01/2016. DEVICE EVALUATION: RESULTS: TWO UNUSED SAMPLES WERE RETURNED FOR EVALUATION. A VISUAL INSPECTION REVEALED NO ISSUES RELATED TO CUSTOMER'S INDICATED FAILURE MODE. BOTH SAMPLES WERE ACTIVATED NORMALLY AND NEITHER SAMPLE HAD A SAFETY MECHANISM FAILURE. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6153743. A MANUFACTURING REVIEW REVEALED NO PROBLEMS OR MANUFACTURING RELATED ISSUES DURING THE QUALITY IN-PROCESS INSPECTIONS. CONCLUSION: AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    Additional Manufacturer Narrative · 1

    RESULTS: ALTHOUGH IT WAS INITIALLY REPORTED THAT A SAMPLE WAS AVAILABLE FOR EVALUATION, A SAMPLE WAS NOT RETURNED BY THE CUSTOMER. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED FOR THIS INCIDENT. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE OF A 22 G X 1 IN. BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM DID NOT RETRACT DURING USE AND A NEW IV HAD TO BE STARTED. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722239 22 G X 1 IN. BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 6153743

    Patients

    Seq Age Sex Outcome Treatment
    1 Other