BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIAVAC CLOSED WOUND SUCTION SYSTEM

    MDR report key: 1934107 · Received December 8, 2010

    Report

    Report Number
    1018233-2010-00133
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Report Date
    November 9, 2010
    Manufacturer
    C.R. BARD, INC.
    Product Code
    GCY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS RETURNED FOR EVAL FINDING A SPLIT NOTED WHERE THE WHITE DRAIN IS CONNECTED TO THE CLEAR ROUND DRAIN. THE POTENTIAL ROOT CAUSE FOR THE SPLIT COULD HAVE BEEN RELATED TO A SHORT SHOT DURING THE INJECTION MOLDING PROCESS. THE SUBASSEMBLY LOT FOR THE MFG LOT NUMBER NGUE0407 DID NOT SHOW ANY DISCREPANCIES RELATED TO DRAIN BREAKAGE. QUALITY ASSURANCE PERFORMED TENSILE STRENGTH TESTING RANDOMLY THROUGHOUT THE LOT. TENSILE STRENGTH OF THE TESTED SAMPLES RANGED FROM 15.89 LBS TO 27.48 LBS SURPASSING A SPECIFICATION OF 9.0 LBS. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER REVIEWED DID NOT REVEAL ANY DISCREPANCIES RELATED TO THE FAILURE. ADDITIONALLY, THE INSTRUCTIONS FOR USE STATES THE FOLLOWING PRECAUTIONS: "ADDITIONAL PERFORATIONS SHOULD NOT BE MADE IN THE DRAIN. AVOID SUTURING THROUGH DRAIN. DRAIN SHOULD LIE FLAT AND IN LINE WITH THE SKIN EXIT AREAS. PARTICULAR CARE SHOULD BE TAKEN TO AVOID ANY OBSTACLES TO THE DRAIN EXIT PATH. DRAIN SHOULD BE CHECKED FOR FREE MOTION DURING CLOSURE TO MINIMIZE THE POSSIBILITY OF BREAKAGE. DRAIN REMOVAL SHOULD BE DONE GENTLY BY HAND. DRAIN SHOULD NOT BE HANDLED WITH POINTED, TOOTHED OR SHARP INSTRUMENTS WHICH COULD CAUSE CUTS OR NICKS AND LEAD TO SUBSEQUENT STRUCTURAL FAILURE OF THE DRAIN. SURGICAL REMOVAL MAY BE NECESSARY IF DRAIN IS DIFFICULT TO REMOVE OR BREAKS". (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPLIT WAS FOUND IN THE WHITE DRAIN BETWEEN THE CONNECTION PORTION OF THE WHITE DRAIN AND THE CLEAR DRAIN. THIS PRODUCT WAS NOT USED ON THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELIAVAC CLOSED WOUND SUCTION SYSTEM GCY C.R. BARD, INC. NA NGUE1418

    Patients

    Seq Age Sex Outcome Treatment
    1 NA