BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUER-EVAC THORACIC CATHETER

    MDR report key: 885328 · Received July 26, 2007

    Report

    Report Number
    3004365956-2007-00028
    Event Type
    Malfunction
    Date Received
    July 26, 2007
    Report Date
    July 12, 2007
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KDQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF INVESTIGATION NOT AVAILABLE AT TIME OF THIS REPORT. CUSTOMER STILL INVESTIGATING INCIDENT AND UNABLE TO PROVIDE INFORMATION. BASED ON ORDER # AND INVOICE # PROVIDED BY CUSTOMER TO TELEFLEX MEDICAL CUSTOMER SERVICE; LOT # 114304-1 IS THE ALLEGED INVOLVED LOT #.

    Description of Event or Problem · 1

    ON JULY 12, 2007, TELEFLEX MEDICAL CUSTOMER SERVICE RECEIVES INFO FROM CUSTOMER IN WHICH THEY ALLEGE THE BLUE TIP OF CATHETER FELL OFF INTO THE PT. NO PT INJURY REPORTED. NO MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUER-EVAC THORACIC CATHETER THORACIC CATHETER 28FR KDQ TELEFLEX MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR