BEUDAMED
    FDA Adverse Event Other Summary report: N

    ASPEN SURGICLA PRODUCTS - BARD PARKER BLADES

    MDR report key: 2703825 · Received June 26, 2012

    Report

    Report Number
    1836161-2012-00002
    Event Type
    Other
    Date Received
    June 26, 2012
    Date of Event
    May 14, 2012
    Report Date
    June 21, 2012
    Manufacturer
    ASPEN SURGICLA PRODUCTS
    Product Code
    GES
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY DID NOT RETURN SAMPLES OF THE BLADE(S) IN QUESTION, HOWEVER, ASPEN HAD BLADES IN STOCK FROM THE SAME LOT AND THEY WERE USED FOR INVESTIGATIONAL PURPOSES. INVESTIGATION INTO THIS DEFECT POINTED US TO AN ISSUE WITH LINER RAW MATERIAL WHICH RESULTED IN A SCAR TO OUR SUPPLIER FOR LINER MOISTURE CONTENT. THEIR EVALUATION SHOWED THAT ONE OF THE EIGHT ROLLS OF LINER SUPPLIED TO US FAILED HUMIDITY CONTENT WHICH MAY BE A CONTRIBUTOR TO THE RUST. THE DEFECT WAS NOT DETECTED ON INCOMING INSPECTION AS IT WAS NOT NECESSARY AT THAT TIME TO SAMPLE ALL EIGHT OF THE MASTER ROLLS. AS A RESULT OF THIS ISSUE, THE PROCEDURE HAS CHANGED AND ALL ROLLS OF PRODUCT FROM THIS SUPPLIER WILL NOW GO THROUGH 100% INCOMING INSPECTION.

    Description of Event or Problem · 1

    BROWN CONTAMINATION WAS FOUND ON MULTIPLE PACKS OF THE #10 BARD PARKER CARBON RIB-BACK SURGICAL BLADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASPEN SURGICLA PRODUCTS - BARD PARKER BLADES #10 BARD PARKER CARBON RIB-BACK BLADE GES ASPEN SURGICLA PRODUCTS 371110 0003755

    Patients

    Seq Age Sex Outcome Treatment
    1