BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD-PARKER STAINLESS STEEL BLADES SIZE 11, STERILE

    MDR report key: 7130973 · Received December 19, 2017

    Report

    Report Number
    1836161-2017-00131
    Event Type
    Injury
    Date Received
    December 19, 2017
    Date of Event
    November 20, 2017
    Report Date
    December 19, 2017
    Manufacturer
    ASPEN SURGICAL PRODUCTS, CALEDONIA
    Product Code
    GES
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE EVALUATION CONDUCTED, LOT 0137217 WAS PACKED PER DHR AND NO NONCONFORMANCE RELATED TO BROKEN BLADE WAS PRESENT. PACKAGING PROCESS HAS ESTABLISHED CONTROLS TO MITIGATE BROKEN BLADE CONDITION, INCLUDING A ¿MEDIO¿ BLADE SENSOR THAT INSPECTS 100% OF PACKED POUCHES ¿ LINER LEVEL PRIOR TO ALUMINUM FOIL PACKAGING. ALSO, NO OTHER COMPLAINT HAS BEING RECEIVED FOR LOT 0137217 RELATED TO BROKEN BLADE CONDITION. THE MOST PROBABLE ROOT CAUSE FOR BROKEN BLADE CONDITION COULD BE MACHINE RELATED; NONETHELESS, THERE ARE ESTABLISHED CONTROLS TO MITIGATE THIS TYPE OF CONDITION SUCH AS: OPERATING TRAININGS, IN-PROCESS INSPECTIONS, QUALITY INSPECTIONS/AUDITS, 100% VISUAL INSPECTION PERFORMED BY CERTIFIED PERSONNEL TO SORT OUT NONCONFORMING PARTS PRIOR TO FINAL ASSEMBLY AND PACKAGING, AND ¿MEDIO¿ BLADE SENSOR. SENSOR IS CHALLENGED AT THE START OF A NEW LOT AND SHIFT. THIS CHALLENGE IS REPEATED FOR BOTH PACKAGING LANES. CHALLENGES WERE SUCCESSFUL. NO QNR WERE OPENED DUE TO BROKEN BLADE CONDITION FOR LOT 0137217. 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. ¿ 100% VISUAL INSPECTION BY CERTIFIED PERSONNEL IS PERFORMED TO SEGREGATE NONCONFORMING MATERIAL, INCLUDING BROKEN BLADES, PRIOR TO ASSEMBLY AND PACKAGING PROCESS. EACH ASSOCIATE PERFORMING 100% INSPECTION PROCESS IS CERTIFIED AND RE-CERTIFIED ON AN ANNUAL BASIS ON BLADE DEFECT CRITERIA¿S. ¿ CAPA (B)(4) WAS INITIATED TO EVALUATE CURRENT CONTROLS IN PLACE CORRECTIVE ACTIONS IDENTIFIED WERE COMPLETED AND CAPA CLOSED ON 10/26/2015. ¿ CAPA (B)(4) WAS ALSO INITIATED TO CONTINUE IN THE MONITORING AND IMPROVEMENT OF CURRENT CONTROL. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    ITEM NUMBER 371211-150 (BARD-PARKER BLADE) BROKE DURING A PATIENT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911108 BARD-PARKER STAINLESS STEEL BLADES SIZE 11, STERILE BARD-PARKER BLADE GES ASPEN SURGICAL PRODUCTS, CALEDONIA 371211-150 0137217

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R