BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    22 G X 1.00 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 6103697 · Received November 15, 2016

    Report

    Report Number
    1710034-2016-00054
    Event Type
    Malfunction
    Date Received
    November 15, 2016
    Date of Event
    October 26, 2016
    Report Date
    November 30, 2016
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY THE MANUFACTURER IS USED. (B)(4). DEVICE EVALUATION: IT IS UNKNOWN IF A SAMPLE IS AVAILABLE FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    CORRECTION FROM INITIAL MDR: DATE RECEIVED BY MANUFACTURER 10/26/2016. DEVICE EVALUATION: RESULT - A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ABNORMALITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBER 6221705. THIS LOT WAS MANUFACTURED BETWEEN 16AUG162016 AND 18AUG2016. CONCLUSION - A SAMPLE WAS NOT RECEIVED FOR INVESTIGATION, THEREFORE AN ABSOLUTE ROOT CAUSE COULD NOT BE DETERMINED. WITHOUT A SAMPLE FOR EVALUATION AND TESTING THERE WAS NO PHYSICAL EVIDENCE TO CONFIRM OR SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE REPORTED DEFECT.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE NEEDLE ON THE SUSPECT DEVICE FAILED TO RETRACT WHEN THE BUTTON WAS PUSHED. THIS DEFECT OCCURRED WITH TWO DEVICES AND NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753307 22 G X 1.00 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER SHIELDED IV CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 6221705

    Patients

    Seq Age Sex Outcome Treatment
    1 Other