BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CSE6L SMALLBORE EXTENSION SET

    MDR report key: 2241332 · Received September 2, 2011

    Report

    Report Number
    2523676-2011-00113
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 8, 2011
    Report Date
    September 2, 2011
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    KGZ
    PMA / PMN Number
    K760385
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE IN THE REPORTED INCIDENT WAS NOT RETURNED FOR EVAL. WITHOUT THE ACTUAL SAMPLE A THOROUGH INVESTIGATION COULD NOT BE PERFORMED. NO SPECIFIC CONCLUSIONS CAN BE DRAWN. THE HOUSE RETAIN SAMPLES FOR THE REPORTED LOT WERE PULLED FOR EVAL. THE RETAINS WERE FUNCTIONALLY TESTED FOR LUER TAPERS, OCCLUSION, AND PRESSURE AND MET ALL SPECS. THE WIDTH OF THE LUER LOCK EARS OF THE ADAPTER AND DIMENSIONS ON THE LUER NUT OF THE ULTRASITE VALVE THAT IMPACT THE ABILITY TO SECURE TO THE FEMALE ADAPTER WERE DIMENSIONALLY TESTED AND MET ALL SPECS. NO ANOMALIES WERE IDENTIFIED THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE ULTRASITE VALVE TO FEMALE ADAPTER ON THIS SET IS A SCREW TOGETHER JOINT AND THE IFU STATES, "TIGHTEN LUER LOCK CONNECTIONS BEFORE USE." WHILE THE REPORTING FACILITY INDICATES THEY DID TIGHTEN THE CONNECTION, THE MEASURE OF TIGHTNESS CANNOT BE CONFIRMED. B BRAUN CURRENTLY DISTRIBUTES A SIMILAR PRODUCT (PRODUCT CODE 473448) WITH AN ULTRASITE VALVE SOLVENT BONDED TO A FEMALE ADAPTER FOR APPLICATIONS WHERE DISCONNECTION IS THIS JOINT IS NOT REQUIRED BY THE USER. THIS SET HAS BEEN RECOMMENDED FOR USE TO THIS FACILITY. THE DHR RECORD WAS REVIEWED FOR THE REPORTED LOT NUMBER AND NO NONCONFORMANCES OR ABNORMALITIES WERE NOTED DURING IN-PROCESS OR FINAL PRODUCT INSPECTION. A REVIEW OF COMPLAINT HISTORY WAS CONDUCTED FOR THE PRODUCT CODE AND LOT NUMBER IDENTIFIED IN THIS REPORTED EVENT. NO ADVERSE QUALITY TRENDS WERE IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS. IF ADD'L PERTINENT INFO BECOMES AVAILABLE, A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: REPORTS ULTRASITE VALVE SEPARATES FROM EXTENSION SET EVEN AFTER BEING HAND TIGHTENED, REPORTS HAS LED TO NUCLEAR MED SPILL. NO SAMPLES SAVED DUE TO NUCLEAR MEDICINE CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CSE6L SMALLBORE EXTENSION SET SMALLBORE EXTENSION SET KGZ B. BRAUN MEDICAL, INC. NA 0061154927

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other