BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7588534 · Received June 11, 2018

    Report

    Report Number
    1836161-2018-00053
    Event Type
    Malfunction
    Date Received
    June 11, 2018
    Date of Event
    May 18, 2018
    Report Date
    May 18, 2018
    Manufacturer
    ASPEN SURGICAL PRODUCTS, CALEDONIA
    Product Code
    GES
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ASPEN SURGICAL RECEIVED A REPORT FROM THE END USER INDICATING THAT BARD-PARKER BLADES WERE DISCOVERED WITH PIN HOLES IN THE STERILE PACKAGING. IN THIS REPORT, IT WAS NOTED THAT THE FOLLOWING LOT NUMBERS WERE DISCOVERED WITH THE ISSUE: 0117929, 0123423, 0138880. NO SAMPLES WERE PROVIDED. PHOTOGRAPHIC EVIDENCE WAS AVAILABLE FOR REVIEW. NO INJURY OR DEATH WAS REPORTED. AN EVALUATION OF THE DHR RECORDS FOR THE LOT NUMBERS LISTED ABOVE WERE PERFORMED. THE REVIEW DETERMINED THERE WERE NO NON-CONFORMANCE'S RELATED TO THE COMPLAINT FOR EACH LOT NUMBER. THE FOLLOWING CONTROLS ARE IN-PLACE TO MITIGATE ¿DAMAGE PACKAGE¿ CONDITION AT ASPEN SURGICAL (B)(4) SITE: INCOMING INSPECTION PROCEDURES FOR ALUMINUM FOIL ROLLS, INCLUDING VISUAL INSPECTION FOR APPEARANCE. IN-PROCESS INSPECTIONS PERFORMED BY PACKAGING PERSONNEL, INCLUDING FOR SEAL INTEGRITY AND POUCH INTEGRITY. ¿HIGH BLADE¿ SENSOR AT PACKAGING LINE WITH ¿HIGH BLADE¿ SENSOR CHALLENGE AT THE BEGINNING OF A NEW LOT AND PER SHIFT. LEAK TEST AT THE BEGINNING OF A NEW LOT AND EVERY 30 MINUTES UNTIL COMPLETION OF THE LOT. ALTHOUGH NO SAMPLES WERE PROVIDED, THE MOST PROBABLE ROOT CAUSE MAY BE FROM FOREIGN MATTER ON THE MACHINE ROLLERS DURING THE PACKAGING PROCESS. IF A SAMPLE IS DETERMINED TO BE RETURNED AND IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE SAMPLE REVIEW, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    ASPEN SURGICAL RECEIVED A REPORT FROM THE END USER INDICATING THAT BARD-PARKER BLADES WERE DISCOVERED WITH PIN HOLES IN THE PACKAGING. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM FOR MULTIPLE LOT NUMBERS. THE COMPLAINT REFERENCES FOR THESE LOT NUMBERS ARE AS FOLLOWS: (B)(4) - 0117929 (1 EA). (B)(4) - 0123423 (3 EA). (B)(4) - 0138880 (1 EA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428539 BARD-PARKER CARBON RIB-BACK BLADES SIZE 15, STERILE BARD-PARKER BLADE GES ASPEN SURGICAL PRODUCTS, CALEDONIA 371115-150 SEE ABOVE

    Patients

    Seq Age Sex Outcome Treatment
    1