BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD-PARKER

    MDR report key: 10404127 · Received August 13, 2020

    Report

    Report Number
    3014527682-2020-00010
    Event Type
    Malfunction
    Date Received
    August 13, 2020
    Report Date
    August 6, 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

    THE BARD-PARKER (ASPEN SURGICAL) BLADES ARE NOT MANUFACTURED BY ROI CPS, LLC BUT ARE PURCHASED FROM ASPEN AND ARE THEN PLACED IN CUSTOM PROCEDURE KITS. THE BLADE MANUFACTURE ASPEN SURGICAL HAS BEEN NOTIFIED OF THE EVENT AND OF THIS REPORT. ROI CPS, LLC RECEIVED A COMPLAINT CLOSURE LETTER FROM THE BLADE MANUFACTURER ASPEN SURGICAL AFTER SUBMITTING A COMPLAINT TO ASPEN SURGICAL.

    Description of Event or Problem · 0

    DISCOVERED DURING PROCEDURE. NO DELAY IN CASE, NO HARM TO PATIENT, BUT THERE WAS PATIENT CONTACT. 10 BLADES IN AT LEAST 10 PACEMAKER PACKS WERE DULL. THE DULL BLADES ARE NOT MANUFACTURED BY ROI CPS, LLC BUT WERE CONTAINED WITHIN ROI CPS, LLC CUSTOM PACK 880010, LOT 78327O AND 77144O.

    Additional Manufacturer Narrative · 1

    THE BARD-PARKER (ASPEN SURGICAL) BLADES ARE NOT MANUFACTURED BY ROI CPS, LLC BUT ARE PURCHASED FROM ASPEN AND ARE THEN PLACED IN CUSTOM PROCEDURE KITS. THE BLADE MANUFACTURE ASPEN SURGICAL HAS BEEN NOTIFIED OF THE EVENT AND OF THIS REPORT.

    Description of Event or Problem · 1

    DISCOVERED DURING PROCEDURE. NO DELAY IN CASE, NO HARM TO PATIENT, BUT THERE WAS PATIENT CONTACT. 10 BLADES IN AT LEAST 10 PACEMAKER PACKS WERE DULL. THE DULL BLADES ARE NOT MANUFACTURED BY ROI CPS, LLC BUT WERE CONTAINED WITHIN ROI CPS, LLC CUSTOM PACK 880010, LOT 78327O AND 77144O.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869500 BARD-PARKER BLADE SURG RIB BCK CARB 10 GES ASPEN SURGICAL 371110 0209336

    Patients

    Seq Age Sex Outcome Treatment
    1