BEUDAMED
    FDA Adverse Event Other Summary report: N

    CV DRAPING PACK A & B

    MDR report key: 1821221 · Received August 26, 2010

    Report

    Report Number
    1417592-2010-00050
    Event Type
    Other
    Date Received
    August 26, 2010
    Date of Event
    July 21, 2010
    Report Date
    August 20, 2010
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    KKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, A PLASTIC SHAVING N THE TRIANGULAR GRADUATE WAS NOT IDENTIFIED AND INADVERTENTLY POURED INTO A SURGICAL SITE WITH THE IRRIGATION SOLUTION. IT WAS SUBSEQUENTLY RETRIEVED AND NO INJURY OR NEGATIVE CONSEQUENCE RESULTED FOR THE PATIENT. WE HAVE NOT HAD SIMILAR ISSUES OF THIS NATURE REPORTED. THE SUPPLIER HAS BEEN NOTIFIED. INSPECTIONS WILL BE INCREASED TO VERIFY THIS ISSUE HAS BEEN ADDRESSED.

    Description of Event or Problem · 1

    WHILE PERFORMING A SURGICAL PROCEDURE, A PIECE OF PLASTIC APPROX 1 INCH LONG FELL INTO THE SURGICAL SITE. IT WAS RETRIEVED AND NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CV DRAPING PACK A & B NONE KKX MEDLINE INDUSTRIES, INC. DYNJ33355B 10DB0848

    Patients

    Seq Age Sex Outcome Treatment
    1 Other