BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD-PARKER STAINLESS STEEL BLADES SIZE 11, STERILE

    MDR report key: 7548795 · Received May 29, 2018

    Report

    Report Number
    1836161-2018-00049
    Event Type
    Malfunction
    Date Received
    May 29, 2018
    Date of Event
    April 26, 2018
    Report Date
    May 2, 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 A REPORT FROM THE DISTRIBUTOR INDICATING THAT BARD-PARKER BLADES ARE BREAKING WHILE IN USE. THE INCIDENT OCCURRED AT THE USER FACILITY. NO INJURY OR DEATHS WERE REPORTED. NO SAMPLES AND NO PHOTOGRAPHIC EVIDENCE WERE AVAILABLE FOR EVALUATION. A LOT NUMBER WAS PROVIDED FOR REVIEW. DEVICE HISTORY RECORD WAS REVIEWED FOR LOT NUMBER 0151445. NO NON-CONFORMANCE'S WERE NOTED THAT COULD BE RELATED TO THE COMPLAINT ISSUE. 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, EXCESSIVE FORCE APPLIED BY END USER DURING SURGERY PROCESS COULD ALSO CAUSE BLADE CONDITION. THE FOLLOWING CONTROLS ARE IN-PLACE TO MITIGATE THIS CONDITION AT ASPEN SURGICAL (B)(4) SITE: EAT 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. DUE TO NO SAMPLE AND NO PHOTOGRAPHIC EVIDENCE AVAILABLE, THE CONDITION OF THE BLADES COULD NOT BE CONFIRMED. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    ASPEN SURGICAL RECEIVED A REPORT FROM THE DISTRIBUTOR INDICATING THAT BARD-PARKER BLADES ARE BREAKING WHILE IN USE. THE INCIDENT OCCURRED AT THE USER FACILITY. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394016 BARD-PARKER STAINLESS STEEL BLADES SIZE 11, STERILE BARD-PARKER BLADE GES ASPEN SURGICAL PRODUCTS, CALEDONIA 371211-150 0151445

    Patients

    Seq Age Sex Outcome Treatment
    1