BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC WING YEL 24GA X .75IN

    MDR report key: 18906584 · Received March 14, 2024

    Report

    Report Number
    1710034-2024-00187
    Event Type
    Malfunction
    Date Received
    March 14, 2024
    Date of Event
    February 19, 2024
    Report Date
    May 30, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903826124
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: DETAILS ON EVENT ADDED TO B5 FROM CUSTOMER. INVESTIGATION RESULTS: THE COMPLAINT THAT THE BLOOD CONTROL VALUE DIDN'T WORK WAS CONFIRMED FROM THE CIRCUMSTANTIAL EVIDENCE OF A DAMAGED SEPTUM; HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED. ONE 24G INSYTE AUTOGUARD UNIT FROM LOT #3153587 WAS PROVIDED FOR INVESTIGATION. THE SAMPLE EXHIBITED EVIDENCE OF USE AND THE ACTUATOR HAD BEEN ADVANCED THROUGH THE BLOOD CONTROL VALVE. THE ACTUATOR WAS REMOVED AND A MICROSCOPIC EXAMINATION OF THE SEPTUM REVEALED A TEAR IN THE SEPTUM AT THE TERMINUS OF ONE SLIT. AS THE DEVICE HAS BEEN OPENED, IT COULD NOT BE DETERMINED WITH CERTAINTY WHETHER THE DAMAGE ORIGINATED DURING MANUFACTURING OR USE OF THE DEVICE. A REVIEW OF THE INSPECTION RECORDS AND QUALITY/MANUFACTURING CONTROLS FOR THE IMPLICATED LOT INDICATED NO ISSUES WITH THE MANUFACTURING PROCESS. NO OTHER SIMILAR COMPLAINTS WERE REPORTED FROM THIS LOT. THE COMPLAINT HAS BEEN DOCUMENTED AND WILL CONTINUE TO BE MONITORED AS PART OF ONGOING EFFORTS TO IDENTIFY POTENTIAL MANUFACTURING RELATED ISSUES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BLOOD CONTROL VALUE MALFUNCTIONED WITH BD INSYTE AUTOG BC WING YEL 24GA X .75IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT BLOOD CONTROL VALUE OF THE IV DIDN'T WORK UPON INSERTION. BLOOD CONTROL VALUE OF THE IV DIDN'T WORK UPON INSERTION. CUSTOMER RESPONSE RECEIVED 02/20/2024 " IV STICK (PRIMARY) WAS A ¿MISS.¿ SECOND IV WAS PLACED WITHOUT INCIDENT."

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION FROM THE CUSTOMER: NO MUCOSAL EXPOSURE TO HCP. PPE WAS WORN BY HCP. NO ADDITIONAL INTERVENTIONS NECESSARY FOR HCP. IT IS UNKNOWN IF THE PATIENT HAD A HISTORY OF BLOODBORNE DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2092948 BD INSYTE AUTOG BC WING YEL 24GA X .75IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3153587 00382903826124

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown