BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD-PARKER

    MDR report key: 10403414 · Received August 13, 2020

    Report

    Report Number
    3014527682-2020-00009
    Event Type
    Malfunction
    Date Received
    August 13, 2020
    Date of Event
    August 6, 2020
    Report Date
    August 13, 2020
    Manufacturer
    ASPEN SURGICAL
    Product Code
    GES
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE DULL ASPEN BLADE IS NOT MANUFACTURED BY ROI CPS, LLC. THE BLADE IS PURCHASED FROM BARD-PARKER (ASPEN SURGICAL) AND IS THEN PLACED IN THE ROI CPS, LLC CUSTOM PROCEDURE TRAY. ROI HAS NOTIFIED THE BLADE MANUFACTURER (ASPEN SURGICAL) OF THE EVENT AND OF THIS REPORT. I HAVE ATTACHED THE LETTER ISSUED TO ROI CPS, LLC FROM ASPEN SURGICAL. THIS WAS RECEIVED AS A RESPONSE FROM ASPEN AFTER ROI CPS, LLC SUBMITTED A COMPLAINT TO ASPEN.

    Description of Event or Problem · 0

    DISCOVERED DURING PROCEDURE. MINIMAL DELAY TO CASE AND NO HARM TO THE PATIENT AS THERE WAS NO PATIENT CONTACT. NO. 10 BLADES IN PERIPHERAL VASCULAR PACKS WERE DULL. THE DULL BLADES WERE CONTAINED WITHIN ROI CPS, LLC CUSTOM PACK 80001801, LOT 79730J.

    Additional Manufacturer Narrative · 1

    THE DULL ASPEN BLADE IS NOT MANUFACTURED BY ROI CPS, LLC. THE BLADE IS PURCHASED FROM BARD-PARKER (ASPEN SURGICAL) AND IS THEN PLACED IN THE ROI CPS, LLC CUSTOM PROCEDURE TRAY. ROI HAS NOTIFIED THE BLADE MANUFACTURER (ASPEN SURGICAL) OF THE EVENT AND OF THIS REPORT.

    Description of Event or Problem · 1

    DISCOVERED DURING PROCEDURE. MINIMAL DELAY TO CASE AND NO HARM TO THE PATIENT AS THERE WAS NO PATIENT CONTACT. NO. 10 BLADES IN PERIPHERAL VASCULAR PACKS WERE DULL. THE DULL BLADES WERE CONTAINED WITHIN ROI CPS, LLC CUSTOM PACK 80001801, LOT 79730J.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869651 BARD-PARKER BLADE SURG RIB BCK CARB 10 GES ASPEN SURGICAL 371110 0209336

    Patients

    Seq Age Sex Outcome Treatment
    1