BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCALPEL HOLDER RED; ASPEN LEAF WITH BARD-PARKER; STERILE

    MDR report key: 18969654 · Received March 25, 2024

    Report

    Report Number
    3002750084-2024-00010
    Event Type
    Malfunction
    Date Received
    March 25, 2024
    Report Date
    July 15, 2024
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    FSM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ASPEN SURGICAL RECEIVED A REPORT FROM THE DISTRIBUTOR INDICATING THAT PRODUCT WAS FOUND WITH SEAL ISSUES. THE DEVICE WAS RETURNED FOR EVALUATION AND THE SEAL ISSUES WERE CONFIRMED. IT WAS DETERMINED THAT THE SCALPEL TRAY IN THE POUCH CONTAINED PART OF THE SPLICE FROM THE TYVEK ROLL THAT ASPEN RECEIVES FROM THE VENDOR. IT WAS MISSED DURING ASPEN'S PRODUCTION RUN BECAUSE THE LABEL FACES UP TO THE OPERATOR AND THE RED SPLICE WAS UNDETRECTED SINCE IT FACES DOWNWARD. AWARENESS TRAINING WAS EXECUTED. THIS CAN BE CONSIDERED THE FINAL REPORT, HOWEVER IF ASPEN IDENTIFIES ANY ADDITIONAL RELEVANT INFORMATION IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    ASPEN SURGICAL RECIEVED A REPORT FROM THE DISTRIBUTOR INDICATING THAT PRODUCT WAS FOUND WITH SEAL ISSUES. THE ACTUAL DEVICE WILL BE RETURNED FOR EVALUATION. THE MANUFACTURING LOT NUMBERS WERE PROVIDED FOR REVIEW. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    ASPEN SURGICAL RECEIVED A REPORT FROM OUTSIDE DISTRIBUTOR INDICATING THAT PRODUCT ST-100 WAS DISCOVERED WITH SEALING ISSUES. NO INJURY/DEATH WAS REPORTED. THIS IS ENTERED IN OUR SYSTEM AS (B)(4).

    Description of Event or Problem · 0

    ASPEN SURGICAL RECEIVED A REPORT FROM OUTSIDE DISTRIBUTOR INDICATING THAT PRODUCT ST-100 WAS DISCOVERED WITH SEALING ISSUES. NO INJURY/DEATH WAS REPORTED. THIS IS ENTERED IN OUR SYSTEM AS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1724 SCALPEL HOLDER RED; ASPEN LEAF WITH BARD-PARKER; STERILE SCALPEL HOLDER FSM ASPEN SURGICAL PRODUCTS, INC. ST-100 359853

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown