BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD BL 22GA X 1.0IN

    MDR report key: 20773071 · Received November 25, 2024

    Report

    Report Number
    9610048-2024-00186
    Event Type
    Malfunction
    Date Received
    November 25, 2024
    Date of Event
    October 17, 2024
    Report Date
    March 3, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    00382903818235
    PMA / PMN Number
    K201075
    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 4183538. 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, TWO (2) PICTURES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE PICTURES, THE NEEDLE RETRACTION FEATURE WAS OBSERVED NOT ACTIVATED. BASED ON THE INVESTIGATION RESULTS, IT IS POSSIBLE THAT THIS INCIDENT RESULTED FROM AN ISSUE WITH THE SPRING FORMATION; IN PARTICULAR, LACK OF SPRING CHECK STATION ADJUSTMENTS, INCORRECT SPRING CHECK CHALLENGE PARTS, OR LACK OF CHECK FREQUENCY IN THE SPRING CHECK STATION. IMPROVEMENTS IN THE SPRING FORMATION MACHINE WERE IMPLEMENTED THROUGH A CORRECTIVE AND PREVENTIVE ACTION PLAN IN AUGUST 2024. A THOROUGH WEEKLY PREVENTIVE CHECK WAS IMPLEMENTED. THE REPORTED LOT NUMBER WAS MANUFACTURED PRIOR TO THE COMPLETION OF THIS PLAN¿S 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

    INITIAL MDR SUBMISSION. 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

    ADDITIONAL INFORMATION RECEIVED ON 11/30/2024 HAS THERE BEEN ANY HARM TO PATIENTS/HEALTHCARE PROFESSIONALS? A: THERE WAS NO HARM TO PATIENTS OR HEALTH PROFESSIONALS. CAN YOU PLEASE CONFIRM THE AFFECTED QUANTITY? A: THERE WERE 3 UNITS. IS THERE ANY PATIENT IMPACT, IF YES, PLEASE EXPLAIN IN DETAILS? A: NO, THERE IS A RISK OF OCCUPATIONAL ACCIDENTS DUE TO SHARPS.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORT, THE MATERIAL PRESENTED PROBLEMS DURING USE. NEEDLE SAFETY LOCK DID NOT WORK (COLLET THE NEEDLE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2014138 INSYTE AUTOGUARD BL 22GA X 1.0IN CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ BECTON DICKINSON 4183538 00382903818235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown