BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 21428136 · Received February 20, 2025

    Report

    Report Number
    9610048-2025-00012
    Event Type
    Malfunction
    Date Received
    February 20, 2025
    Date of Event
    February 6, 2025
    Report Date
    May 13, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    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

    H.3. 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 38181214 AND LOT NUMBER 4122904. THE REVIEW DID NOT REVEAL ANY ABNORMALITIES DETECTED 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 RETURNED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE PICTURE, THE NEEDLE WAS OBSERVED CROSSED THROUGH THE CATHETER AND THE PRODUCT WAS USED. IT IS WORTH NOTING THAT IF THE NEEDLE WAS TRANSFIXED DUE TO A MANUFACTURING PROBLEM, IT WOULD NOT BE POSSIBLE TO USE THE PRODUCT. BASED ON THE INVESTIGATION RESULTS, IT IS MOST LIKELY THAT THIS INCIDENT RESULTED FROM THE USE OF THE PRODUCT. IT CAN BE INFERRED THAT DURING THE 360-DEGREE ROTATION BEFORE PUNCTURE, THE CATHETER MAY HAVE BEEN PUSHED FORWARD, CAUSING THE NEEDLE TO TRANSFIX THE CATHETER DURING PUNCTURE. 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 PIERCED THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: WHEN AN ATTEMPT IS MADE TO PUNCTURE WITH THE CATHETER, THE PATIENT'S SKIN DOES NOT CUT, SO ACCESS IS LOST. ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 11, 2025. IS THERE ANY IMPACT ON THE PATIENT? IF SO, PLEASE EXPLAIN IN DETAIL? ONLY THE LOSS OF ACCESS AND HAVING TO DO THE PROCESS AGAIN, WHICH CAN CAUSE PAIN FOR THE PATIENT. DATE OF EVENT OCCURRED ON DD/MM/YYYY? 06/02/2025.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1637072 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4122904 00382903818129

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown