BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELEFLEX MEDICAL AORTIC PUNCH, DISP.

    MDR report key: 1575303 · Received December 8, 2009

    Report

    Report Number
    3004365956-2009-00074
    Event Type
    Malfunction
    Date Received
    December 8, 2009
    Date of Event
    November 12, 2009
    Report Date
    November 12, 2009
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    DWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL METHOD: DEVICE HISTORY REVIEW. RESULTS: THE DEVICE HISTORY REVIEW FOR THE REPORTED LOT NUMBER SHOWS THAT THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO SPECS. A VISUAL INSPECTION WAS PERFORMED ON THE SAMPLES AND THE REPORTED DEFECT WAS FOUND. CONCLUSIONS: NO ROOT CAUSE CAN BE ESTABLISHED AT THIS TIME DUE TO THE FACT THAT THE DEFECT FOUND ON THE PRODUCT SEEMS TO BE A SCRATCH AND NOT A HOLE. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO SHIPPING DAMAGE WHEN THE PRODUCT WAS SENT TO THE CUSTOMER FROM DISTRIBUTION CENTER. THE SAMPLE WILL BE SENT TO R&D FOR ANALYSIS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THERE IS A SMALL PIN HOLE ON THE PACKAGE. THIS ISSUE WAS FOUND PRIOR TO USE, AT INSPECTION LEVEL. NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELEFLEX MEDICAL AORTIC PUNCH, DISP. AORTIC PUNCH DWS TELEFLEX MEDICAL NA 02F0901230

    Patients

    Seq Age Sex Outcome Treatment
    1