BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD-PARKER

    MDR report key: 10622922 · Received October 2, 2020

    Report

    Report Number
    3014527682-2020-00016
    Event Type
    Malfunction
    Date Received
    October 2, 2020
    Date of Event
    September 29, 2020
    Report Date
    October 2, 2020
    Manufacturer
    ASPEN SURGICAL
    Product Code
    GES
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ROI CPS, LLC HAS REPORTED A THIS EVENT TO THE BLADE MANUFACTURER (ASPEN SURGICAL). ROI CPS, LLC RECEIVED A COMPLAINT CLOSURE LETTER FROM ASPEN SURGICAL IN RESPONSE TO A COMPLAINT FILED IN JUNE 2020 WHICH OUTLINES THAT THE BLADE MANUFACTURER OPENED A CAPA TO ADDRESS THE DULL BLADES. I HAVE ATTACHED THE COMPLAINT RESPONSE LETTER TO THIS RECORD. TO DATE, THE COMPLAINTS RECEIVED BY ROI CPS, LLC HAVE BEEN FOR THE SAME MANUFACTURER ITEM NUMBER AND LOT NUMBER THAT IS OUTLINED IN THE RESPONSE LETTER.

    Description of Event or Problem · 1

    10 BLADE IN PACKS WERE DULL. DISCOVERED DURING CASE. THERE WAS PATIENT CONTACT; HOWEVER, NO HARM TO PATIENT AND NO DELAY TO CASE. THE DULL BLADES WERE CONTAINED WITHIN ROI CPS, LLC CUSTOM PACK 880096033 (NUERO PACK) LOT NUMBER 79925AG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1083020 BARD-PARKER BLADE SURG RIB BCK BARB 10 GES ASPEN SURGICAL 371110 0209336

    Patients

    Seq Age Sex Outcome Treatment
    1