BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 8479878 · Received April 3, 2019

    Report

    Report Number
    9610048-2019-00143
    Event Type
    Malfunction
    Date Received
    April 3, 2019
    Date of Event
    March 19, 2019
    Report Date
    August 31, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION:REVIEW OF DHR REVEALED ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. REVIEW DISCLOSED NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT THE OUTCOME OF THE QUALITY OF THE PRODUCT RELEVANT TO THE DEFECT STATED IN THE PIR. THE DEFECT NEEDLE RETRACTION FAILURE; COULD NOT BE IDENTIFIED OR CONFIRMED, AND CAUSE COULD NOT BE DETERMINED, AS THE UNITS DESCRIBED IN THE PRODUCT INCIDENT REPORT WERE NOT RETURNED FOR EVALUATION AND TESTING.

    Additional Manufacturer Narrative · 0

    CORRECTION: D3. MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SANDY, UT. G1. MANUFACTURING LOCATION: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SANDY, UT. THE PRODUCT IS MADE IN SANDY, UT AND PACKAGED IN JUIZ DE FORA, BR. THIS REPORT ERRANTLY REPORTED THE MANUFACTURER AS JUIZ DE FORA, BR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SAFETY MECHANISM ON THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER DIDN'T ACTIVATE TO RETRACT THE NEEDLE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: "THE SAFETY MECHANISM IS NOT ACTIVATING IN ORDER TO RETRACT THE NEEDLE. THERE WAS NO DAMAGE TO THE PATIENT / HEALTH PROFESSIONAL. THERE WAS NO NEED FOR MEDICAL OR SURGICAL INTERVENTION. THERE WAS NO NEEDLE STICK ACCIDENT."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SAFETY MECHANISM ON THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER DIDN'T ACTIVATE TO RETRACT THE NEEDLE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: "THE SAFETY MECHANISM IS NOT ACTIVATING IN ORDER TO RETRACT THE NEEDLE. THERE WAS NO DAMAGE TO THE PATIENT / HEALTH PROFESSIONAL. THERE WAS NO NEED FOR MEDICAL OR SURGICAL INTERVENTION. THERE WAS NO NEEDLE STICK ACCIDENT."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER PHONE#: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAFETY MECHANISM ON THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER DIDN'T ACTIVATE TO RETRACT THE NEEDLE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THE SAFETY MECHANISM IS NOT ACTIVATING IN ORDER TO RETRACT THE NEEDLE. THERE WAS NO DAMAGE TO THE PATIENT / HEALTH PROFESSIONAL. THERE WAS NO NEED FOR MEDICAL OR SURGICAL INTERVENTION. THERE WAS NO NEEDLE STICK ACCIDENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271901 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 7234790

    Patients

    Seq Age Sex Outcome Treatment
    1 Other