BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOGICAL STOPCOCK SET

    MDR report key: 1203281 · Received October 14, 2008

    Report

    Report Number
    9616567-2008-00054
    Event Type
    Malfunction
    Date Received
    October 14, 2008
    Date of Event
    June 16, 2008
    Report Date
    June 16, 2008
    Manufacturer
    SMITH MEDICAL, ASD.
    Product Code
    DRS
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L LOT # 1228566. ELEVEN SAMPLES - ONE BROKEN AT THE DOME AND 10 INTACT WERE RECEIVED. THE 10 INTACT UNITS WERE TESTED AND FOUND TO BREAK EASILY. THE BREAKS WERE CLEAN WITH NO VISIBLE CRACKS. IT WAS THEREFORE, DETERMINED THAT THE DOME HAD INADVERTENTLY BEEN BONDED TO THE STOPCOCK USING CYCLOHEXANONE INSTEAD OF DICHLOROMETHANE. TO CORRECT THIS, IDENTIFICATION OF THE SOLVENT DISPENSERS WAS CHANGED IN SEPT 2008 TO REDUCE THE LIKELIHOOD OF THIS RECURING. THE ISSUE WAS REVIEWED WITH MANUFACTURING PERSONNEL. THE LOTS IN QUESTION WERE MANUFACTURED BEFORE THESE CORRECTIONS WERE IN PLACE. THE DEVICE HISTORY WAS REVIEWED WITH NO RELATED ISSUE FOUND. SMITHS WAS ABLE TO CONFIRM THE ISSUE AND DETERMINE THE CAUSE. CORRECTIVE ACTIONS HAVE BEEN PUT IN PLACE. NO ADDITIONAL ACTION IS NECESSARY AT THIS TIME. SMITHS CONSIDERS THIS MDR CLOSED WITH THIS REPORT. SMITHS RECOGNIZES THAT THIS REPORT IS NOT BEING SUBMITTED WITHIN THE REQUIRED TIMEFRAME. MDR REPORTING DEADLINE BASED UPON THE DATE THE INFO WAS RECEIVED WAS JULY 16, 2008. SMITHS CONTINUES TO BE COMMITTED TO REGULATORY COMPLIANCE AND WILL MAKE EVERY EFFORT TO ENSURE THAT THIS DOES NOT RECUR.

    Description of Event or Problem · 1

    THE REPORTER STATED THE CONNECTION BROKE APART. THERE IS NO ADDITIONAL INFO AVAILABLE. THERE WAS NO PATIENT INJURY OR TREATMENT REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOGICAL STOPCOCK SET PRESSRUE MONITORING SET DRS SMITH MEDICAL, ASD. NA 1216207

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK