BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUBLESS FLAT SILICONE DRAIN

    MDR report key: 2432912 · Received January 6, 2012

    Report

    Report Number
    1018233-2011-00519
    Event Type
    Malfunction
    Date Received
    January 6, 2012
    Date of Event
    December 1, 2011
    Report Date
    December 9, 2011
    Manufacturer
    C.R. BARD, INC.
    Product Code
    GBX
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNKNOWN SO THE DEVICE RECORD COULD NOT BE REVIEWED. AS A FINISHED GOOD, QA PERFORMS RANDOM VISUAL INSPECTIONS FOR DAMAGED COMPONENTS PRIOR TO PRODUCT RELEASE. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING CAUTIONS TO AVOID THE POSSIBILITY OF DRAIN DAMAGE OR BREAKAGE: "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. DRAINS SHOULD BE CHECKED FOR FREE MOTION DURING CLOSURE TO MINIMIZE THE POSSIBILITY OF BREAKAGE. DRAIN REMOVAL SHOULD BE DONE GENTLY BY HAND. DRAIN 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 THE DRAIN WAS NOTED BROKEN UPON REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUBLESS FLAT SILICONE DRAIN GBX C.R. BARD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK