BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUER-EVAC ADULT-PED DRY/WET SYSTEM

    MDR report key: 1970881 · Received January 4, 2011

    Report

    Report Number
    3004365956-2011-00012
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    December 9, 2010
    Report Date
    December 9, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KDQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE HISTORY RECORD (DHR) REVIEW AND COMPLAINT HISTORY REVIEW. RESULTS: DHR REVIEW FOR THE REPORTED LOT NUMBER SHOWED NO ISSUES OR DISCREPANCIES WHICH COULD POTENTIALLY RELATE TO THE COMPLAINT REPORTED. NO NON-CONFORMANCE REPORTS WERE ORIGINATED FOR THE LOT IN QUESTION THAT CAN BE ASSOCIATED TO THE COMPLAINT REPORTED. THE DHR SHOWS THAT THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO SPECIFICATIONS. COMPLAINT HISTORY REVIEW FOR ONE YEAR WAS CONDUCTED ON THE CATALOG NUMBER IN QUESTION FROM (B)(4) 2009 TO (B)(4) 2010. (B)(4). AN INVESTIGATION WAS PERFORMED REVIEWING THE ENTIRE PROCESS STARTING FROM THE MATERIAL RECEIVED AND UNTIL IT DEPARTS TO THE STERILIZER AND IT WAS FOUND THAT THE PROPER CONTROLS ARE ESTABLISHED IN ORDER TO DETECT IF THE ORANGE FLOAT IS PRESENT AND WORKING ACCORDING TO SPECIFICATIONS. THIS TEST IS PERFORMED AT 100% ON ALL UNITS AS PER PROTOCOL. VERIFICATION IS ESTABLISHED ON QUALITY INSTRUCTIONS (FLOAT ELEVATION AND DROP TEST). CONCLUSIONS: NO EVALUATION WILL BE PERFORMED. NO CONCLUSION CAN BE DRAWN. CUSTOMER COMPLAINT CANNOT BE CONFIRMED DUE TO LACK OF SAMPLE FOR INVESTIGATION. NO CORRECTIVE ACTION CAN BE ESTABLISHED AT THIS TIME.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE FLOAT DOES NOT APPEAR IN THE INDICATOR WINDOW AT MAXIMUM SUCTION CAPACITY FROM THE WALL UNIT. THE UNIT WAS REPLACED WITHOUT A PROBLEM. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUER-EVAC ADULT-PED DRY/WET SYSTEM PLUER-EVAC CHEST DRAINAGE SYSTEM KDQ TELEFLEX MEDICAL NA 02K1000181

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK