BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILE TIP CLEANER

    MDR report key: 7601980 · Received June 14, 2018

    Report

    Report Number
    1836161-2018-00059
    Event Type
    Malfunction
    Date Received
    June 14, 2018
    Date of Event
    April 16, 2018
    Report Date
    May 21, 2018
    Manufacturer
    ASPEN SURGICAL PRODUCTS, CALEDONIA
    Product Code
    GEI
    PMA / PMN Number
    K030339
    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 IN THE SEAL OF THE POUCH. THE ACTUAL DEVICE WAS NOT RETURNED FOR EVALUATION. THE MANUFACTURING LOT NUMBER ALONG WITH PHOTOGRAPHIC EVIDENCE WAS PROVIDED FOR REVIEW. THE LOT NUMBERS ASSOCIATED WITH THE REPORT ARE AS FOLLOWS: 152222, 140026. THE DISTRIBUTOR INDICATED THAT THE DEFECT WAS FOUND DURING INCOMING INSPECTION. A REVIEW OF THE PHOTOS CONFIRMED THE ISSUE FROM THE DISTRIBUTOR. ANALYSIS OF THE FINISHED GOOD LOT NUMBERS 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 PARTS IN THE SEAL 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 WERE NOTIFIED OF THIS ISSUE DURING THE DAILY UPDATE MEETINGS. 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 STERILE TIP CLEANER WAS FOUND IN THE SEAL OF THE POUCH. THE ITEM WAS NOT IN USE. NO INJURY/DEATH WAS REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM FOR MULTIPLE LOT NUMBERS. THE COMPLAINT REFERENCES FOR THESE LOT NUMBERS ARE AS FOLLOWS: (B)(4) - LOT 152222, (B)(4) - LOT 140026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442026 STERILE TIP CLEANER TIP CLEANER GEI ASPEN SURGICAL PRODUCTS, CALEDONIA TC-100A SEE ABOVE

    Patients

    Seq Age Sex Outcome Treatment
    1