BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROSYTE AUTOGUARD 26G INTRO ONLY

    MDR report key: 16802284 · Received April 24, 2023

    Report

    Report Number
    9610847-2023-00092
    Event Type
    Malfunction
    Date Received
    April 24, 2023
    Date of Event
    March 6, 2023
    Report Date
    March 14, 2024
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    DYB
    UDI-DI
    50382903840088
    PMA / PMN Number
    K020834
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DATE OF BIRTH: PATIENT¿S BIRTHDAY WAS NOT PROVIDED, (B)(6) 2023 WAS USED BASED ON AGE OF PATIENT. THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON 04-APR-2023. MEDWATCH REPORT # (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP MDR FOR DEVICE EVALUATION: IT WAS REPORTED ONE SIDE OF THE SHEATH BROKE OFF COMPLETELY RIGHT AT THE PURPLE PART OF THE INTRODUCER. TO AID IN THE INVESTIGATION, ONE PICTURE WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE DEFECT CAN BE OBSERVED IN THE PHOTO. THERE IS NO ACTIVITY OR OPERATION DURING THE MANUFACTURING PROCESS THAT THIS DEFECT COULD BE ATTRIBUTED TO; THEREFORE, THE FAILURE MODE IS ASSOCIATED TO THE SUPPLIER. THE SUPPLIER INVESTIGATION CONCLUDED PROCESSES OUTSIDE OF THE SUPPLIER WERE LIKELY THE CONTRIBUTOR TO THE FAILURE MODE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER: 384008, LOT: 2060080. THE REVIEW REVEALED THERE WERE NO INTERNAL REJECTS RELATED TO THE REPORTED ISSUE DURING THIS ORDER. ACCORDING TO CONTROL PLAN FOR THE MANUFACTURING PROCESS, THIS LOT WAS ACCEPTED AND MEET ACCEPTANCE CRITERIA. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION, BD WAS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INTROSYTE AUTOGUARD 26G INTRO ONLY SHEATH BROKE OFF COMPLETELY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AS I WENT TO PEEL THE SHEATH, ONE SIDE OF THE SHEATH BROKE OFF COMPLETELY RIGHT AT THE PURPLE PART OF THE INTRODUCER.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1046942 INTROSYTE AUTOGUARD 26G INTRO ONLY CATHETER INTRODUCER DYB BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 384008 2060080 50382903840088

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Female