BEUDAMED
    FDA Adverse Event Other Summary report: N

    LINER CANNSTR SUCT 3000CC DISP

    MDR report key: 1246435 · Received November 19, 2008

    Report

    Report Number
    1423507-2008-00092
    Event Type
    Other
    Date Received
    November 19, 2008
    Date of Event
    April 23, 2008
    Report Date
    November 19, 2008
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KDQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    UNFORTUNATELY, THE PRODUCT SAMPLE WAS NOT PROVIDED BY THE CUSTOMER; THEREFORE, AN EVAL OF THE COMPLAINT DEVICE FOR DEFICIENCY OF CONSTRUCTION COULD NOT BE PERFORMED. ONE LOT NUMBER REPORTED, J803-087, DOES NOT CORRESPOND TO PRODUCT (B) (4) THAT HAD THE REPORTED ISSUE. THE DHR FOR THE OTHER LOT NUMBER REPORTED, J803-102, WAS REVIEWED AND NO NON-CONFORMANCE WAS NOTED. FUNCTIONAL STRENGTH INTEGRITY EVAL FOR THE CRD PRODUCT CODE (B) (4) VERIFIED THAT LOT TO LOT IMPLOSION RESISTANCE TESTING IS PERFORMED. DIMENSIONAL WALL THICKNESS EVAL IS PERFORMED MONTHLY TO EVALUATE CRD LID COMPONENT WALL THICKNESS SHIFT. ALL CAVITIES EVALUATED IN THE MONTH OF MANUFACTURE WERE WITHIN SPECIFICATION AND NO MOLD REFURBISHMENT MAINTENANCE WAS REQUIRED FOR 'THIN LID WALL'. WITHOUT THE ACTUAL SAMPLE, NO DEFINITE CONCLUSION CAN BE DRAWN. HOWEVER, NO OUT OF SPECIFICATION CONDITIONS HAVE BEEN IDENTIFIED. THE POSSIBILITY DOES NOT EXIST THAT THE UNIT MAY HAVE BEEN DAMAGED DURING PROCESSING AND/OR SUBSEQUENT PACKAGING AND HANDLING INCLUDING AT THE CUSTOMER SITE RESULTING IN THE LOSS OF STRUCTURAL INTEGRITY. IN ADDITION, CUSTOMER MISUSE MAY ALSO CONTRIBUTE TO A POTENTIAL IMPLOSION EVENT.

    Description of Event or Problem · 1

    ACCORDING TO INFO RECEIVED FROM FDA, "DURING A SIGMOID COLON RESECTION WITH TAKE DOWN OF COLOSTOMY AND EEA STAPLED ANASTOMOSIS, THE SUCTION CANISTER EXPLODED CONTAMINATING THE FIELD. THE LID SPLIT IN SEVERAL PIECES." LOT NUMBER J803-102 WAS TAKEN FROM A SUCTION LINER BOX IN THE HOSPITAL HALLWAY AND MAY NOT BE THE EXACT NUMBER OF THE LINER USED IN THE PROCEDURE IN QUESTION.

    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 J803-102 OR J803-087

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK