BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 19529143 · Received June 13, 2024

    Report

    Report Number
    9610048-2024-00068
    Event Type
    Malfunction
    Date Received
    June 13, 2024
    Date of Event
    May 22, 2024
    Report Date
    October 1, 2024
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    00382903818235
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 38182314 AND LOT NUMBER 3241304. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE (1) PICTURE SAMPLE WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE PICTURE, THE NEEDLE WAS OBSERVED THROUGH THE CATHETER AND IT WAS USED. IT IS POSSIBLE THAT THIS INCIDENT RESULTED FROM THE USE OF THE PRODUCT. WHEN PERFORMING THE 360-DEGREE ROTATION DURING PUNCTURE, THE CATHETER MAY HAVE BEEN PUSHED FORWARD, WITH THE NEEDLE TRANSFIXING THE CATHETER DURING PUNCTURE. IF THE CATHETER WAS TRANSFIXED DUE TO THE MANUFACTURING PROCESS, IT WOULD HAVE BEEN UNUSABLE. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD NEEDLE THROUGH CATHETER THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: THE HOSPITAL TECHNICIANS INFORMED US THAT THE CATHETER INTO THE PATIENT'S VEIN, IT HAS A DEFECTIVE BEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1184395 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 3241304 00382903818235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown