BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD-PARKER CARBON RIB-BACK BLADES SIZE 15, STERILE

    MDR report key: 7305837 · Received March 1, 2018

    Report

    Report Number
    1836161-2018-00025
    Event Type
    Malfunction
    Date Received
    March 1, 2018
    Date of Event
    March 2, 2017
    Report Date
    January 31, 2018
    Manufacturer
    ASPEN SURGICAL PRODUCTS, CALEDONIA
    Product Code
    GES
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ASPEN SURGICAL RECEIVED MEDWATCH REPORT # (B)(4) WHICH WAS REQUESTED BY ASPEN SURGICAL DURING A MONTHLY REVIEW OF THE FDA'S MAUDE DATABASE. AS INDICATED IN THE REPORT, A SURGICAL TECH WAS LOADING THE BARD-PARKER BLADE INTO A KNIFE HANDLE BEFORE THE PROCEDURE WAS TO START AND THE BLADE BROKE INTO THREE PIECES. USER FACILITY DID NOT REPORT THE INCIDENT TO ASPEN SURGICAL. NO CUSTOMER INFORMATION WAS AVAILABLE IN THE MAUDE REPORT. PART NUMBER AND MANUFACTURING LOT NUMBER WAS AVAILABLE. EVENT OCCURRED IN A HOSPITAL. NO INJURY OR DEATH WAS REPORTED. BASED ON THE EVALUATION CONDUCTED, LOT 0118976 WAS PACKED PER DHR AND NO NON-CONFORMANCE RELATED TO THE BROKEN BLADE WERE PRESENT. PACKING PROCESS HAS ESTABLISHED CONTROLS TO MITIGATE BROKEN BLADE CONDITION, INCLUDING A BLADE SENSOR THAT INSPECT 100% OF PACKED POUCHES LINER LEVEL PRIOR TO ALUMINUM FOIL PACKAGING. THE FOLLOWING CONTROLS ARE IN-PLACE TO MITIGATE ¿BROKEN BLADE¿ CONDITION AT ASPEN SURGICAL LAS PIEDRAS SITE: HEAT TREATMENT IN-PROCESS AT THE BEGINNING AND END OF EACH LOT ARE INSPECTED FOR DIMENSION INTEGRITY USING A PIN GAUGE, FLATNESS GAUGE AND PERFORATION LENGTH GAUGE, DUCTILITY TEST, AND HARDNESS TEST. HEAT TREATMENT QUALITY INSPECTIONS AT THE BEGINNING AND END OF EACH LOT ARE INSPECTED FOR DIMENSION INTEGRITY USING A PIN GAUGE, FLATNESS GAUGE AND PERFORATION LENGTH GAUGE, DUCTILITY TEST, AND HARDNESS TEST. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    ASPEN SURGICAL RECEIVED INFORMATION FROM A MAUDE EVENT REPORT (FOI) WHICH WAS REQUESTED BY ASPEN SURGICAL. THE REPORT WAS IDENTIFIED DURING A MONTHLY REVIEW OF THE FDA'S MAUDE DATABASE. THE REPORT INDICATED THAT A BARD-PARKER BLADE BROKE UPON LOADING INTO THE KNIFE HANDLE. THE INCIDENT OCCURRED AT THE USER FACILITY. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149061 BARD-PARKER CARBON RIB-BACK BLADES SIZE 15, STERILE BARD-PARKER BLADE GES ASPEN SURGICAL PRODUCTS, CALEDONIA 371115-150 0118976

    Patients

    Seq Age Sex Outcome Treatment
    1