BEUDAMED
    FDA Adverse Event Other Summary report: N

    LINER CANNSTR SUCT 3000CC DISP

    MDR report key: 1070709 · Received July 3, 2008

    Report

    Report Number
    1423507-2008-00051
    Event Type
    Other
    Date Received
    July 3, 2008
    Date of Event
    June 16, 2008
    Report Date
    July 1, 2008
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KDQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT SAMPLE WAS NOT PROVIDED BY THE CUSTOMER, THEREFORE, AN EVALUATION OF THE COMPLAINT DEVICE FOR DEFICIENCY OF CONSTRUCTION COULD NOT BE PERFORMED. HOWEVER THE DESCRIPTION PROVIDED ADEQUATELY DESCRIBES THE EVENT AND PROVIDES A BASIS FOR THIS INVESTIGATION PROCESS. AN IMPLOSION EVENT WAS DISCARDED WHERE SEVERE DAMAGE TO THE LID AND DISPOSABLE LINER OCCURRED. IN ADDITION, IT WAS STATED THAT THE HARD REUSABLE CANISTER HAD SPLIT. DISCUSSIONS WITH KEY QUALITY, MARKETING, AND ENGINEERING PERSONNEL HAVE OCCURRED. KEY POINTS OF THE DISCUSSION INCLUDE: WITHOUT THE ACTUAL SAMPLE NO DIMENSIONAL OF VISUAL INSPECTIONS CAN BE PERFORMED. IT WAS STATED IN THE REPORT THAT "THE LINER HAD BEEN USED FOR A NUMBER OF SURGICAL PROCEDURES WITHOUT BEING CHANGED IN BETWEEN PATIENTS" THE PRODUCT LABELING, THROUGH SYMBOLS AND WORDING, DEFINES USAGE "FOR SINGLE USE ONLY". THE PRODUCT IS DESIGNED TO MEET IMPLOSION RESISTANCE REQUIREMENTS PER ISO (B) (4) "MEDICAL SUCTION EQUIPMENT - PART 3: SUCTION EQUIPMENT POWERED FROM VACUUM OR PRESSURE SOURCE."

    Description of Event or Problem · 1

    THE SUCTION LINER HAD BEEN USED DURING A NEUROLOGICAL SURGICAL PROCEDURE. FOLLOWING THE PROCEDURE THE VACUUM TO THE LINER WAS KEPT ON AND THE ATTACHED PATIENT SUCTION TUBING WAS PLACED UNDER THE PATIENT'S PILLOW IN CASE SUCTION WAS REQUIRED DURING EXTUBATION. THE LINER WAS THEN DESCRIBED AS "EXPLODING' WITH THE LID SHATTERING IN PIECES. A MEMBER OF STAFF WAS CONTAMINATED WITH THE CONTENTS OF THE LINER. IT WAS ALSO REPORTED THAT THE OUTER REUSABLE CANISTER HAD SPLIT. THE STAFF COULD NOT VERIFY WHETHER THIS DAMAGE WAS PRE-EXISTING OR HAD OCCURRED FOLLOWING THE INCIDENT. THE LINER HAD BEEN USED FOR A NUMBER OF SURGICAL PROCEDURES WITHOUT BEING CHANGED IN BETWEEN PATIENTS. THE TECHNICAL SUPPORT MANAGER HAS STATED THAT THE INCIDENT WILL BE REPORTED TO THE (B) (6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINER CANNSTR SUCT 3000CC DISP SUCTION CANISTER LINER KDQ CARDINAL HEALTH 65651-530 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention