BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARVEST GRAFT DELIVERY SYSTEM

    MDR report key: 3440404 · Received September 9, 2013

    Report

    Report Number
    1225520-2013-00013
    Event Type
    Malfunction
    Date Received
    September 9, 2013
    Date of Event
    August 27, 2013
    Report Date
    September 9, 2013
    Manufacturer
    HARVEST TECHNOLOGIES CORPORATION
    Product Code
    FMF
    PMA / PMN Number
    K043261
    Removal / Correction Number
    1225520-09/10/2013/001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IN TOTAL HARVEST RECEIVED 13 REPORTS OF GDP-10 LEAKS AT THE LUER CONNECTOR. EACH REPORT HAS BEEN SUBMITTED TO FDA AS A SEPARATE MDR. AS PART OF AN INVESTIGATION GDP-10 PRODUCT WAS INSPECTED AND 2/135 LUER CONNECTORS EXHIBITED A CRACKS. BASED ON THIS INVESTIGATION FIELD ACTION WILL BE INITIATE AND GDP-10 PRODUCT WILL BE RECALLED. THE DISTRICT OFFICE WILL BE NOTIFIED.

    Description of Event or Problem · 1

    SITE REPORTED THAT GDP-10 HARVEST GRAFT DELIVERY SYSTEM WAS INSPECTED UPON OPENING AND THAT THE LUER CONNECTOR WAS CRACKED. WE OPENED THE GDP AND INSPECTED THE BUTTERFLIES. WE FOUND A CRACK IN TWO OF THEM SO WE DID NOT USE THEM. THERE WAS NO IMPACT, INJURY OR DELAYS. WE DID NOT USE THESE BUTTERFLY'S AND WERE ABLE TO USE THE OTHER CONNECTORS IN THE GDP KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449371 HARVEST GRAFT DELIVERY SYSTEM PISTON SYRINGE FMF HARVEST TECHNOLOGIES CORPORATION GDP-10 GDP-10-0051

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR