BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD-PARKER

    MDR report key: 10465400 · Received August 28, 2020

    Report

    Report Number
    3014527682-2020-00012
    Event Type
    Malfunction
    Date Received
    August 28, 2020
    Report Date
    August 28, 2020
    Manufacturer
    ASPEN SURGICAL
    Product Code
    GES
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    SAMPLES OF THE ASPEN BLADES WERE SENT BY ROI CPS, LLC TO ASPEN SURGICAL ON (B)(6) 2020 AFTER THE INITIAL COMPLAINTS WERE RECEIVED. ROI CPS, LLC REQUESTED THAT THE MANUFACTURE OF THE BLADES PERFORM AN INVESTIGATION AND PROVIDE THEIR CORRECTIVE ACTIONS. ROI CPS, LLC RECEIVED A COMPLAINT CLOSURE LETTER FROM ASPEN SURGICAL. I AM ATTACHING IT TO THIS REPORT.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT EVERY #10 BLADE WITH THAT LOT NUMBER (0209336) WAS OPENED AND COMPARED WITH OTHER BLADES WAS DULL. THE DULL BLADES WERE CONTAINED WITHIN ROI CPS, LLC CUSTOM PACK 800731001-OPEN HEART PACK A&B AND 800766003-LAMINECTOMY PACK.

    Additional Manufacturer Narrative · 1

    SAMPLES OF THE ASPEN BLADES WERE SENT BY ROI CPS, LLC TO ASPEN SURGICAL ON 7/1/2020 AFTER THE INITIAL COMPLAINTS WERE RECEIVED. ROI CPS, LLC REQUESTED THAT THE MANUFACTURE OF THE BLADES PERFORM AN INVESTIGATION AND PROVIDE THEIR CORRECTIVE ACTIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT EVERY #10 BLADE WITH THAT LOT NUMBER (0209336) WAS OPENED AND COMPARED WITH OTHER BLADES WAS DULL. THE DULL BLADES WERE CONTAINED WITHIN ROI CPS, LLC CUSTOM PACK (B)(4) OPEN HEART PACK A&B AND (B)(4) LAMINECTOMY PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933791 BARD-PARKER BLADE SURGICAL RIB BCK CARB 10 GES ASPEN SURGICAL 371110 0209336

    Patients

    Seq Age Sex Outcome Treatment
    1