BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RICHARD-ALLAN REGULAR TIP PEN W/ RULER AND 6-UP LABELS

    MDR report key: 11002210 · Received December 14, 2020

    Report

    Report Number
    1836161-2020-00061
    Event Type
    Malfunction
    Date Received
    December 14, 2020
    Date of Event
    November 15, 2020
    Report Date
    November 16, 2020
    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 ALSO PROVIDED FOR REVIEW. THE DISTRIBUTOR INDICATED THAT THE DEFECTS WERE FOUND DURING INCOMING INSPECTION. A REVIEW OF THE PHOTOS AND SAMPLE 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. ACCORDING TO THE MANUFACTURING PROCESS, THESE PARTS ARE LOADED INTO RECESSED POCKETS ON A PACKAGING MACHINE PER SPECIFIED WORK INSTRUCTIONS. PATIENT LABELS AND RULERS ARE LOADED INTO THE MACHINE BY AN AUTOMATED AUTO-LOADER, WHICH DISPENSES EACH COMPONENT INTO THE POCKET. IF INCORRECTLY LOADED OR NOT ORIENTATED PROPERLY, THE PRODUCT INTERFERES WITH THE SEALING PROCESS. THE PRODUCT THAT WAS EVALUATED WAS DETERMINED THAT THE MACHINE CAUSED THE PARTS TO DROP FROM TOO HIGH OF A HEIGHT. THIS CAUSED THE PRODUCT TO NOT BE PLACED CORRECTLY. THEREFORE, THE LIKELY ROOT CAUSE IS ATTRIBUTED TO MACHINE ISSUE. THIS ISSUE WAS IMPROVED WITH AN UPDATE TO THE PNEUMATIC CYLINDER TO ALLOW FOR MORE CONTROL OF THE DROP HEIGHT INTO THE POCKET FOR BETTER PRODUCT PLACEMENT. 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 SURGICAL MARKING PEN WAS FOUND WITH DEFECTIVE SEALS. THE ITEM WAS NOT IN USE. NO INJURY/DEATH WAS REPORTED. CUSTOMER REPORTED MULTIPLE LOTS FOR THE SAME ISSUE. THE LOT NUMBERS AND THEIR RESPECTIVE COMPLAINT NUMBERS ARE AS FOLLOWS: (B)(4), LOT 233293. (B)(4), LOT 223954.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1467545 RICHARD-ALLAN REGULAR TIP PEN W/ RULER AND 6-UP LABELS MARKING PEN FZZ ASPEN SURGICAL PRODUCTS, CALEDONIA 2650 SEE ABOVE

    Patients

    Seq Age Sex Outcome Treatment
    1