BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 21746357 · Received April 1, 2025

    Report

    Report Number
    9610048-2025-00048
    Event Type
    Malfunction
    Date Received
    April 1, 2025
    Date of Event
    March 13, 2025
    Report Date
    May 12, 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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 38182314 AND LOT NUMBER 5002445. 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. IT IS POSSIBLE THAT THIS INCIDENT RESULTED FROM CHALLENGE TEST PARTS. IF THE CHALLENGE TEST PARTS ARE NOT CONFIGURED WITH THE MILDEST DEFECT (NOT APPARENT), IT MAY NOT BE DETECTED BY THE VISION SYSTEM. THE CHALLENGE TEST IS PERFORMED ONCE PER SHIFT AND VISUAL INSPECTIONS FOR TRANSFIXED CATHETER ARE PERFORMED THROUGH OUT THE SHIFTS EVERY TWO (2) HOURS. HOWEVER, NO ISSUES RELATED TO THIS DEFECT WERE FOUND DURING THE PRODUCTION PROCESS. 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 NEEDLE PIERCED THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SOME UNITS HAVE HAD THE SILICONE TUBE TORN, MAKING IT IMPOSSIBLE TO USE. ADDITIONAL INFORMATION RECEIVED ON 03/25/2025 IS THERE ANY PATIENT IMPACT, IF YES, PLEASE EXPLAIN IN DETAILS? A: YES, WE NEED TO PUNCTURE THE PATIENT AGAIN. EXPOSING THE PATIENT TO MULTIPLE PUNCTURES. CAN YOU PLEASE CONFIRM THE DATE OF EVENT? A: 13/03/2025 CAN YOU PLEASE CONFIRM AFFECTED QUANTITY? A: EVIDENCE OF 1 UNIT, WE'VE HAD OTHER REPORTS BEFORE, BUT NO RECORD OF THE BATCH. WAS THERE A NEED FOR MEDICAL AND/OR SURGICAL INTERVENTION DUE TO THE INCIDENCE (IMAGING TESTS, SURGERY, DRUG ADMINISTRATION, ETC.)? (DETAIL) A: NO WAS THERE EXPOSURE OF BLOOD/CHEMOTHERAPY TO MUCOUS MEMBRANES (EYES, NOSE AND MOUTH) OR SKIN? IF YES, INDICATE WHETHER THE EXPOSURE WAS FROM THE PATIENT OR THE PRACTITIONER AND WHAT MEASURES WERE TAKEN. (DETAIL) A: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750388 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 5002445 00382903818235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown