BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UMBILICAL CORD CLAM, NS

    MDR report key: 4752176 · Received May 5, 2015

    Report

    Report Number
    1033554-2015-00013
    Event Type
    Malfunction
    Date Received
    May 5, 2015
    Date of Event
    October 19, 2012
    Report Date
    May 1, 2015
    Manufacturer
    DEROYAL INDUSTRIES
    Product Code
    FOD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: DEROYAL IS THE MFR OF FINISHED GOOD 6833NS, 89-6311, AND 89-6310 IDENTIFIED BY THE CUSTOMER. WHEN THE CUSTOMER EXPERIENCED THE ISSUE THEY COULD NOT PROVIDE THE TRAY NUMBER IN WHICH THE REPORTED UMBILICAL CORD CLAMP WAS UTILIZED OUT OF. THE REPORT IS DESCRIBED AS "CLAMP WAS DIFFICULT TO CLOSE AND THEN LATER RELEASED". THE QC COMPLAINT SPECIALIST CONTACTED THE CUSTOMER ON (B)(4) 2012 TO OBTAIN ADD'L INFO. IT WAS STARTED BY THE CUSTOMER THAT "WHEN IT WAS TRYING TO SNAP CLOSE IT WOULD NOT STAY, WOULD NOT STAY SHUT." THE CUSTOMER ALSO DID NOT KNOW IF THE PROD WAS FULLY CLOSED AND IDENTIFIED A POSSIBLE END USER ERROR. THE CUSTOMER ALSO INDICATED THE SAMPLE IS NOT AVAILABLE TO BE RETURNED TO DEROYAL FOR REVIEW. THE RAW MATERIAL LEVEL AS OBTAINED FOR THE UMBILICAL CORD CLAMP FOR EACH OF THE FINISHED GOODS IDENTIFIED BY THE CUSTOMER. RAW MATERIALS (B)(4) WAS OBTAINED, BUT HAS MULTIPLE VENDORS LISTED WITHIN THE JDE OPERATING SYS. WITHOUT THE LOT INFO THE VENDOR CAN NOT BE IDENTIFIED. CORRECTION: A CORRECTION ACTION HAS NOT BEEN TAKEN . ROOT CAUSE ANALYSIS: UNDETERMINED: THE ROOT CAUSE COULD NOT BE DETERMINED DUE TO LACK OF INFO. CORRECTIVE ACTION AND/OR SYSTEMIC CORRECTION ACTION TAKEN: DUE TO THE ROOT CAUSE DETERMINATION A CORRECTIVE ACTION HAS NOT BEEN TAKEN. PREVENTIVE ACTION: DUE TO THE ROOT CAUSE DETERMINATION A PREVENTATIVE ACTION HAS NOT BEEN TAKEN. THIS REPORT IS BEING FILED DUE TO A RETROSPECTIVE REVIEW OF COMPLAINTS. THIS COMPLAINT HAS BEEN REOPENED FOR FURTHER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE FILED IF FURTHER INVESTIGATION PROVIDES INFO WHICH CHANGES THE CONTENT OF THIS REPORT.

    Description of Event or Problem · 1

    CLAMP WAS DIFFICULT TO CLOSE AND THEN LATER RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292972 UMBILICAL CORD CLAM, NS DEVICE, OCCLUSION, UMBILICAL FOD DEROYAL INDUSTRIES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention