BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFESHEATH SEALING ADAPTER

    MDR report key: 1961645 · Received December 28, 2010

    Report

    Report Number
    2529252-2010-00016
    Event Type
    Malfunction
    Date Received
    December 28, 2010
    Date of Event
    November 29, 2010
    Report Date
    December 28, 2010
    Manufacturer
    THOMAS MEDICAL PRODUCTS
    Product Code
    DYB
    PMA / PMN Number
    K003731
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NARRATIVE: THE PRODUCT WAS RETURNED TO THE MFG SITE FOR INVESTIGATION. WITHIN THE SAMPLE PROVIDED, SOME OF THE POUCHES WERE FOUND TO BE OPEN, OR THE SEALS WERE FOUND TO BE BELOW THE LOWER SPECS LIMIT. INVESTIGATION REVEALED THAT THE SEALING BAR OF THE SEALER WAS OPERATING BELOW THE SET POINT ON THE SEALER'S CONTROL UNIT. A RECALL OF THE AFFECTED PRODUCT HAS BEEN INITIATED AND WAS REPORTED TO FDA PER 21 CFR PART 806 ON (B)(4), 2010.

    Description of Event or Problem · 1

    A SITE REPORTED THAT DURING A ROUTINE CONTROL OF THE STOCK, IT WAS DISCOVERED THAT THE SEALING SEAM OF ONE OF THE SAFESHEATH SEALING ADAPTERS WAS OPEN. THERE WAS NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFESHEATH SEALING ADAPTER CATHETER INTRODUCER DYB THOMAS MEDICAL PRODUCTS FCL-141-01 S32067

    Patients

    Seq Age Sex Outcome Treatment
    1