BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOGICAL CATH LAB SET

    MDR report key: 1109078 · Received August 8, 2008

    Report

    Report Number
    9616567-2008-00059
    Event Type
    Malfunction
    Date Received
    August 8, 2008
    Report Date
    July 11, 2008
    Manufacturer
    SMITHS MEDICAL, ASD
    Product Code
    DRS
    PMA / PMN Number
    K94377
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE SAMPLE WAS RECEIVED WITH THE FEMALE LUER LOCK (FLL) MISSING. EXAMINATION OF THE AFFECTED AREA SHOWED THE TUBING HAD BEEN BROKEN OFF INSIDE THE FLL. THE TUBING BREAK WAS A BRITTLE BREAK AND SUBSEQUENT TEARING BY EVIDENCE OF JAGGED AND SHINNY EDGES. THE TUBING MEASURED WITHIN SPECIFICATION. SMITHS WAS ABLE TO CONFIRM THE ISSUE DUE TO THE EXTERNAL FORCE BEING APPLIED TO THE COMPONENT UNTIL THE TUBING BROKE. NO ADDITIONAL ACTION IS NECESSARY AT THIS TIME. SMITHS CONSIDERS THIS MDR CLOSED WITH THIS REPORT.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE COMPONENT ARRIVED WITH THE LINE NOT CONNECTED TO THE LUER END. THERE WAS NO PT INJURY OR TREATMENT REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOGICAL CATH LAB SET PRESSURE MONITORING SET DRS SMITHS MEDICAL, ASD NA 1266465

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK