BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RICHARD-ALLAN FINE TIP W/ RULER AND 6-UP LABELS- STERILE

    MDR report key: 11893566 · Received May 27, 2021

    Report

    Report Number
    1836161-2021-00022
    Event Type
    Malfunction
    Date Received
    May 27, 2021
    Date of Event
    May 5, 2021
    Report Date
    May 5, 2021
    Manufacturer
    ASPEN SURGICAL PRODUCTS, CALEDONIA
    Product Code
    FZZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ASPEN SURGICAL RECEIVED A REPORT FROM THE DISTRIBUTOR INDICATING THAT PRODUCT WAS FOUND WITH SEAL ISSUES. THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. PHOTOGRAPHIC EVIDENCE ALONG WITH THE MANUFACTURING LOT NUMBER WERE PROVIDED FOR REVIEW. THE DISTRIBUTOR INDICATED THAT THE DEFECTS WERE FOUND DURING INCOMING INSPECTION. A REVIEW OF THE SAMPLES CONFIRMED THE ISSUE FROM THE DISTRIBUTOR. ANALYSIS OF THE FINISHED GOOD LOT NUMBER WAS REVIEWED. NO NON-CONFORMANCE'S WERE NOTED DURING THE MANUFACTURING PROCESS. A REVIEW OF THE SAMPLE CONFIRMED THE REPORTED PROBLEM OF PART IN SEAL. THE PATIENT LABELS ARE LOADED INTO A MAGAZINE, THESE ALLOW FOR THE COMPONENT ALIGNMENT INTO THE POCKETS DURING THE DISPENSING PROCESS. DURING CONSULTATION WITH THE SUBJECT MATTER EXPERT (SME), THESE COMPONENTS CAN SLIDE OUT OF THE SEATED POCKET AND HAVE A HIGH TENDENCY FOR STATIC FRICTION LEADING TO POTENTIAL DELAY IN DISPENSING FROM THE LOADER ITSELF. THIS IS BECAUSE THE PRODUCT LIKES TO CLING TO ITSELF LEADING TO AN IMPROPER DISPENSE OF THE COMPONENT. ALTHOUGH THE ROOT CAUSE COULD NOT BE CONFIRMED, THIS THE LIKELY EVENT THAT CAUSED THE ISSUE. PRODUCTION TEAM WAS NOTIFIED OF THE REPORTED EVENT. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    ASPEN SURGICAL RECEIVED A REPORT FROM THE DISTRIBUTOR INDICATING THAT A PEN WAS DISCOVERED WITH A SEALING ISSUE. THE ITEM WAS NOT IN USE. NO INJURY/DEATH WAS REPORTED. THIS REPORT WAS FILED UNDER OUR COMPLAINT HANDLING SYSTEM AS NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795233 RICHARD-ALLAN FINE TIP W/ RULER AND 6-UP LABELS- STERILE MARKING PEN FZZ ASPEN SURGICAL PRODUCTS, CALEDONIA 2630 241121

    Patients

    Seq Age Sex Outcome Treatment
    1