BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VIPER¿ LT SYSTEM

    MDR report key: 17137262 · Received June 15, 2023

    Report

    Report Number
    1119779-2023-00666
    Event Type
    Malfunction
    Date Received
    June 15, 2023
    Date of Event
    May 22, 2023
    Report Date
    May 23, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    OOI
    UDI-DI
    00382904428396
    PMA / PMN Number
    K140447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN . E.1. STE 101 3548 MERIDIAN ST WHATCOM. H6: INVESTIGATION SUMMARY. A FAILURE OF A DOOR FAILURE WAS REPORTED ON A VIPER LT INSTRUMENT (P/N 442839, S/N (B)(6)). THE CUSTOMER REPORTED THAT THE INSTRUMENT DOOR WOULD NOT CLOSE. A BD FIELD SERVICE ENGINEER WAS DISPATCHED AND DISCOVERED THE DOOR LOCK WAS BROKEN. THE BD FSE REPLACED THE DOOR LOCK AND DOOR SENSOR TO RESOLVE THE ISSUE. THIS IS A CONFIRMED FAILURE OF A BD PRODUCT. BD QUALITY DID NOT RECEIVE ANY RETURNED MATERIALS FOR REVIEW. REVIEW OF DEVICE HISTORY RECORD FOR (B)(6) IS NOT REQUIRED FOR THIS COMPLAINT AS THIS COMPLAINT DOES NOT ALLEGE AN EARLY LIFE FAILURE OR FAILURE AT INSTALLATION AND THE CONFIGURATION HAS CHANGED SINCE RELEASE FROM MANUFACTURING DUE TO SERVICE REPAIRS/PMS. SERVICE HISTORY FOR (B)(6) WAS REVIEWED AND REVEALED NO PREVIOUS COMPLAINTS RELATED TO DOOR ISSUES. THE ROOT CAUSE WAS ATTRIBUTED TO A FAILURE OF THE DOOR LOCK. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VIPER¿ LT SYSTEM HAS A DOOR HARDWARE ISSUE AND IT WILL NOT LATCH. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTED DOOR HARDWARE ISSUE / WILL NOT CLOSE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2024525 BD VIPER¿ LT SYSTEM INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS OOI BECTON, DICKINSON & CO. (SPARKS) 442839 00382904428396

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown