BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAUT ADAPT UNIVERSAL SEAL PORT, 5/12MM X 100MM

    MDR report key: 2062071 · Received March 16, 2011

    Report

    Report Number
    3003898360-2011-00102
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Report Date
    February 21, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    DTL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS RECEIVED BY MFR, HOWEVER, INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A F/U REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE EVENT REPORTED AS: DURING INSERTION OF A NEEDLE HOLDER (WITH A 5/8 NEEDLE), A PART OF THE SEAL SEPARATED AND FELL INSIDE AREA (SITUS). COMPLAINT STATES THAT THE PART WAS ABLE TO BE REMOVED DURING SURGERY WITHOUT ANY PROBLEMS OR OCCURRENCES. THERE WAS NO REPORTED IMPACT TO THE PT. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAUT ADAPT UNIVERSAL SEAL PORT, 5/12MM X 100MM TAUT ADAPTOR DTL TELEFLEX MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1