BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DR FOG TREATED SPONGE, STERILE (40 EACH/ BOX)

    MDR report key: 12554328 · Received September 30, 2021

    Report

    Report Number
    1836161-2021-00035
    Event Type
    Malfunction
    Date Received
    September 30, 2021
    Date of Event
    September 1, 2021
    Report Date
    September 1, 2021
    Manufacturer
    ASPEN SURGICAL PRODUCTS, CALEDONIA
    Product Code
    OCT
    PMA / PMN Number
    K932449
    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 NOT RETURNED FOR EVALUATION. THE MANUFACTURING LOT NUMBER WAS PROVIDED FOR REVIEW. PHOTOGRAPHIC EVIDENCE WAS PROVIDED FOR REVIEW AS WELL. THE DISTRIBUTOR INDICATED THAT THE DEFECTS WERE FOUND DURING INCOMING INSPECTION. A REVIEW OF THE PHOTOS 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 MANUALLY LOADED INTO RECESSED POCKETS ON A PACKAGING MACHINE PER SPECIFIED WORK INSTRUCTIONS. IF INCORRECTLY LOADED OR NOT ORIENTATED PROPERLY, THE PRODUCT INTERFERES WITH THE SEALING PROCESS. THEREFORE A LIKELY ROOT CAUSE FOR THE DEFECT MAY BE ATTRIBUTED TO AN OPERATOR ERROR. THE IFU WHICH IS RECEIVED WITH THE PRODUCT, ALONG WITH THE POUCH LABEL, IDENTIFIES THIS FAILURE MODE WITH THE SYMBOL "DO NOT USE IF PACKAGE IS DAMAGED". THIS INDICATES THAT THE DEVICE SHOULD NOT BE USED IF THE PRODUCTS STERILE BARRIER SYSTEM OR ITS PACKAGING IS COMPROMISED. ADDITIONALLY, PRODUCTION SUPERVISORS AND OPERATIONS WERE NOTIFIED OF THIS ISSUE. 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 DR FOG SPONGE WAS DISCOVERED WITH A SEALING ISSUE. 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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1449365 DR FOG TREATED SPONGE, STERILE (40 EACH/ BOX) ANTI-FOG OCT ASPEN SURGICAL PRODUCTS, CALEDONIA DF-3120 SEE ABOVE

    Patients

    Seq Age Sex Outcome Treatment
    1