BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 21032817 · Received December 29, 2024

    Report

    Report Number
    9610048-2024-00205
    Event Type
    Malfunction
    Date Received
    December 29, 2024
    Date of Event
    December 13, 2024
    Report Date
    April 18, 2025
    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 FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 38182314 AND LOT NUMBER 4155993. 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) UNOPENED SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY TEAM. THE SAMPLE WAS EXAMINED, AND NO VISUAL DAMAGE WAS OBSERVED THAT COULD HAVE LED TO THE REPORTED ISSUES. THE SAMPLE WAS EVALUATED FOR PENETRATION AND DRAG TESTS TO ASSESS THE QUALITY OF THE NEEDLE TIP, THE QUALITY OF THE CATHETER TIP, AND THE SILICONIZATION OF THE CATHETER. ALL RESULTS WERE FOUND TO BE WITHIN SPECIFICATIONS. ACCORDING TO THE CUSTOMER'S DESCRIPTION, "IT HAS A SAFETY LOCK, BUT WHEN IT "LEVERS" TOO FAST IT ENDS UP BURSTING," THIS MAY BE RELATED TO THE CUSTOMER'S PERCEPTION OF THE USE OF THE PRODUCT. BASED ON THE ANALYSIS OF THE SAMPLE RECEIVED, WE CAN CONCLUDE THAT THE PRODUCT IS WITHIN THE SPECIFICATIONS, AND IT WAS NOT POSSIBLE TO CONFIRM THIS REPORT. BASED ON THE INVESTIGATION RESULTS, A CAUSE RELATED TO THE MANUFACTURING PROCESS COULD NOT BE DETERMINED FOR THE REPORTED INCIDENT. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD NEEDLE RETRACTION FAST. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUES TO ENGLISH: REASON: BAD CATHETER FOR PUNCTURE, ESPECIALLY WITH CHILDREN WHO TEND TO MOVE, IT HAS A SAFETY LOCK, BUT WHEN ACTIVATED IT ¿LEVERAGES¿ TOO QUICKLY AND ENDS UP BURSTING, LOSING THE VEIN, IT DOESN'T SLIDE EASILY AFTER CATCHING THE VEIN. ADDITIONAL INFORMATION RECEIVED ON DECEMBER 24, 2024 HAS THERE BEEN ANY HARM TO THE PATIENT/HEALTH PROFESSIONAL? (DETAIL) - NO. COULD YOU TELL US HOW MANY PEOPLE HAVE BEEN AFFECTED? - WE'VE HAD A LOT OF REPORTS OF THIS CATHETER, I DON'T KNOW EXACTLY HOW MANY PEOPLE HAVE BEEN AFFECTED, BUT THERE ARE QUITE A FEW. COULD YOU SEND A PHOTO OF A SAMPLE OF THE REPORTED EVENT? - UNFORTUNATELY I DON'T HAVE ONE. HAS ANVISA BEEN NOTIFIED? IF SO, WHAT WAS THE NOTIFICATION NUMBER? - YES, 2024 12 002399 DATE THE EVENT OCCURRED: - 13/12.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1730199 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 4155993 00382903818235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown