BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 21713803 · Received March 27, 2025

    Report

    Report Number
    9610048-2025-00028
    Event Type
    Malfunction
    Date Received
    March 27, 2025
    Date of Event
    January 5, 2025
    Report Date
    April 14, 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 4183541. 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. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE COULD NOT BE DETERMINED FOR THE REPORTED EVENT. HOWEVER, THE PROBABLE ROOT CAUSE COULD BE RELATED TO SPRING FORMATION DURING MANUFACTURING. THE OPERATION AND MAINTENANCE CORRECTIONS PERFORMED VARIOUS ADJUSTMENTS AND ALIGNMENTS THAT MAY HAVE BEEN RELATED TO THIS DEFECT. A CORRECTIVE AND PREVENTIVE ACTION PLAN WAS IMPLEMENTED TO PREVENT THE OCCURRENCE OF THIS TYPE OF DEFECT. HOWEVER, THE LOT REPORTED WAS MANUFACTURED PRIOR TO THIS CAPA IMPLEMENTATION. 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. (B)(6).

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM PORTUGUESE TO ENGLISH: ABOCATH N 22 THE SAFETY DEVICE HAS NOT RETRACTED THE NEEDLE. LOT 4183541 BRAND BD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2472081 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 4183541 00382903818235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown