BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASPEN SURGICAL PRODUCTS, BARD PARKER BLADES

    MDR report key: 2645951 · Received June 28, 2012

    Report

    Report Number
    1836161-2012-00004
    Event Type
    Malfunction
    Date Received
    June 28, 2012
    Date of Event
    May 17, 2012
    Report Date
    June 28, 2012
    Manufacturer
    ASPEN SURGICAL PRODUCTS
    Product Code
    LRO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION HAS NOT BEEN RECEIVED BY ASPEN SURGICAL AS YET. WHEN THE SUSPECT PRODUCT ARRIVES IT WILL BE SENT OUT FOR STERILIZATION. UPON IT'S RETURN FROM STERILITY, IT WILL BE FORWARDED TO OUR (B)(4) PLANT FOR A FULL INVESTIGATION INTO THIS EVENT. WE WILL FILE A FOLLOW-UP REPORT WHEN WE RECEIVE THE COMPLETE INVESTIGATION. MEDLINE INDUSTRIES REPORT #(B)(4). ADDITIONAL INFO FROM THE IMPORTER REPORT: (B)(6). COMMON DEVICE NAME: SURGICAL BLADE WITH CUSTOM PACK. MFR NAME: ASPEN SURGICAL PRODUCTS, INC. INITIAL REPORTER: (B)(6).

    Description of Event or Problem · 1

    THE SURGICAL BLADE FROM A CUSTOMER EXTREMITY PACK BROKE AS THE SURGEON MADE THE INITIAL CUT DURING A CARPAL TUNNEL PROCEDURE. THE BROKEN TIP WAS RETRIEVED WITHOUT INJURY TO THE PT. THE BLADE IS BEING RETURNED TO US IN TWO PIECES AND WILL BE SENT OUT FOR STERILIZATION UPON ITS RETURN. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASPEN SURGICAL PRODUCTS, BARD PARKER BLADES BARD PARKER SAFETY BLADE SIZE 10 LRO ASPEN SURGICAL PRODUCTS 371115 0001816

    Patients

    Seq Age Sex Outcome Treatment
    1