BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD PARKER

    MDR report key: 10459341 · Received August 27, 2020

    Report

    Report Number
    3014527682-2020-00011
    Event Type
    Malfunction
    Date Received
    August 27, 2020
    Date of Event
    August 17, 2020
    Report Date
    August 27, 2020
    Manufacturer
    ASPEN SURGICAL
    Product Code
    GES
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ROI CPS, LLC HAS NOTIFIED THE ASPEN OF THE EVENT AND OF THIS REPORT. ROI HAS REQUESTED THAT ASPEN SURGICAL PROVIDE THEIR CORRECTIVE AND PREVENTIVE ACTIONS RELATED TO THIS EVENT. ROI CPS, LLC RECEIVED A COMPLAINT CLOSURE RESPONSE LETTER FROM ASPEN SURGICAL AFTER SUBMITTING A COMPLAINT TO THE BLADE MANUFACTURER.

    Description of Event or Problem · 0

    DISCOVERED DURING PROCEDURE, NO DELAY TO CASE, NO HARM TO PATIENT, BUT THERE WAS PATIENT CONTACT. THE #10 BLADES WERE DULL. THE DULL BLADES WERE CONTAINED WITHIN ROI CPS, LLC CUSTOM PACK 880135 (MINOR NEURO) LOT 79280AB.

    Additional Manufacturer Narrative · 1

    ROI CPS, LLC HAS NOTIFIED THE ASPEN OF THE EVENT AND OF THIS REPORT. ROI HAS REQUESTED THAT ASPEN SURGICAL PROVIDE THEIR CORRECTIVE AND PREVENATIVE ACTIONS RELATED TO THIS EVENT.

    Description of Event or Problem · 1

    DISCOVERED DURING PROCEDURE, NO DELAY TO CASE, NO HARM TO PATIENT, BUT THERE WAS PATIENT CONTACT. THE #10 BLADES WERE DULL. THE DULL BLADES WERE CONTAINED WITHIN ROI CPS, LLC CUSTOM PACK 880135 (MINOR NEURO) LOT 79280AB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928125 BARD PARKER BLADE SURG RIB BCK CARB 10 GES ASPEN SURGICAL 371110 0209336

    Patients

    Seq Age Sex Outcome Treatment
    1