BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 18647009 · Received February 5, 2024

    Report

    Report Number
    9610048-2024-00011
    Event Type
    Malfunction
    Date Received
    February 5, 2024
    Date of Event
    November 22, 2023
    Report Date
    June 6, 2024
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    00382903818129
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 38181214 AND LOT NUMBER 3132130. 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. AS NEITHER PHYSICAL SAMPLES NOR PICTURE SAMPLES WERE AVAILABLE FOR RETURN, A THOROUGH SAMPLE ANALYSIS COULD NOT BE COMPLETED. IF THE AFFECTED SAMPLES BECOME AVAILABLE FOR THIS INCIDENT OR ANY POTENTIAL FUTURE INCIDENTS, WE WOULD GREATLY APPRECIATE THE OPPORTUNITY TO REVIEW THEM. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE COULD NOT BE DETERMINED FOR THE REPORTED EVENT. 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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD CATHETER RUPTURED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: ABOCATH SHOWING A RUPTURE IN THE SILICONE AT THE TIME OF PHLEBOTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2087119 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 3132130 00382903818129

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown