BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 21272910 · Received January 30, 2025

    Report

    Report Number
    9610048-2025-00005
    Event Type
    Malfunction
    Date Received
    January 30, 2025
    Date of Event
    December 23, 2024
    Report Date
    March 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
    PHARMACIST
    Health Professional
    Yes

    Narratives

    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. E1. ADDRESS INFORMATION WAS NOT PROVIDED, THEREFORE, XX WAS USED AS A PLACE HOLDER.

    Additional Manufacturer Narrative · 0

    TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE (1) PICTURE SAMPLE WAS RECEIVED. THROUGH EXAMINATION OF THE PICTURE, THE SAFETY NEEDLE RETRACTION DEVICE WAS OBSERVED PARTIALLY ACTIVATED. THE PARTIAL RETRACTION IS MOST LIKELY DUE TO SOME DAMAGE IN THE CYLINDER PREVENTING FULL ACTIVATION OF THE NEEDLE; HOWEVER, THE PRESENCE OF THE PHYSICAL SAMPLE WOULD BE NECESSARY FOR A THOROUGH ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 38182314 AND LOT NUMBER 4242824. ALTHOUGH THERE WERE NO QUALITY NOTIFICATIONS OR NON-CONFORMITY REPORTS FOR THIS LOT, A CORRECTIVE MAINTENANCE ORDER WAS FOUND DURING THE PRODUCTION PROCESS FOR AN ADJUSTMENT OF SENSORS AND PRESSURE WHICH MAY BE RELATED TO THIS REPORTED INCIDENT. IT IS PROBABLE THAT THE CYLINDER COMPONENT WAS DAMAGED AS A RESULT OF A PRESSURE VARIATION OR FAILURE IN THE READING OF THE SENSOR IN THE MANUFACTURING STATION. THIS DAMAGE MAY HAVE THEN PREVENTED THE NEEDLE FROM FULLY RETRACTING. 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 DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: WE HAVE RECEIVED A TECHNICAL COMPLAINT REGARDING THE INSYTE AUTOGUARD 22G X 1,00 PECA (38182314) BD, THE CUSTOMER REPORTS THAT THE NEEDLE (METAL PART) DOES NOT RETRACT WHEN THE DEVICE IS ACTIVATED. ADDITIONAL INFORMATION RECEIVED ON 01/22/2025. IS THERE ANY PATIENT IMPACT, IF YES, PLEASE EXPLAIN IN DETAIL? A: NO CAN YOU PLEASE CONFIRM DATE OF EVENT? A: 23/12/2024. 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

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792046 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 4242824 00382903818235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown