BEUDAMED
    FDA Adverse Event Injury Summary report: N

    24 G X 0.56 IN. BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 5926573 · Received September 2, 2016

    Report

    Report Number
    1710034-2016-00039
    Event Type
    Injury
    Date Received
    September 2, 2016
    Date of Event
    August 23, 2016
    Report Date
    August 29, 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
    NH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. RESULTS: A SAMPLE IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6112722. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER USING A 24 G X 0.56 IN. BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER, A CLINICIAN PRESSED THE SAFETY ACTIVATION BUTTON BUT THE NEEDLE DID NOT RETRACT AND HE/SHE OBTAINED A CONTAMINATED NEEDLE STICK INJURY. THE MOTHER OF THE SOURCE PATIENT (AN INFANT) HAD LAB WORK DRAWN, WHICH WAS NEGATIVE FOR BLOOD BORNE PATHOGENS. THE CLINICIAN FOLLOWED UP WITH THE FACILITY¿S OCCUPATIONAL HEALTH CLINIC BUT IT IS UNKNOWN IF HE/SHE RECEIVED ANY LAB WORK OR MEDICATION FOR THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577864 24 G X 0.56 IN. BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 6112722

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention