BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 17844635 · Received September 29, 2023

    Report

    Report Number
    1710034-2023-01131
    Event Type
    Malfunction
    Date Received
    September 29, 2023
    Date of Event
    September 11, 2023
    Report Date
    January 12, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT CLOSED TO AA CODE NEEDLE PREMATURE RETRACTION WHICH IS NOT MDR REPORTABLE. INVESTIGATION FINDINGS: THE COMPLAINT OF A BROKEN CATHETER WAS NOT CONFIMED; HOWEVER, THE PHOTOGRAPH AND RETURNED 24G INSYTE AUTOGUARD UNIT FROM LOT #2003277 SHOWED THE CATHETER POSITIONED WITHIN THE NEEDLE COVER AND SEPARATE FROM THE NEEDLE, WHICH INDICATES THE CATHETER WAS LIKELY SEPARATED FROM THE NEEDLE WHEN THE NEEDLE COVER WAS REMOVED. THE NEEDLE WAS FULLY RETRACTED WITHIN THE SHIELD (GRIP/BARREL). THE REPORTED ISSUE CAN HAPPEN DURING MANUFACTURING OR HANDLING AFTER THE PRODUCT IS OPENED. MISORIENTATION OR MANIPULATION OF THE NEEDLE COVER CAN ACTIVATE THE SAFETY MECHANISM AND CAUSE THE CATHETER TO BECOME WEDGED WITHIN THE NEEDLE COVER. A REVIEW OF THE INSPECTION RECORDS AND QUALITY/MANUFACTURING CONTROLS FOR THE IMPLICATED LOT INDICATED NO ISSUES WITH THE MANUFACTURING PROCESS. MANUFACTURING CONTROLS ARE IN PLACE TO MITIGATE THE OCCURRENCE OF THIS TYPE OF FAILURE. AS THIS TYPE OF DAMAGE CAN OCCUR EITHER DURING USE OR DURING MANUFACTURING, COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WAS BROKEN. THE FOLLOWING WAS TRANSLATED FROM (B)(6) TO ENGLISH: CATHETER BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316683 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 2003277

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown