BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4 FR. S/L POWERPICC - NURSING FULL (TLS)

    MDR report key: 2092636 · Received May 10, 2011

    Report

    Report Number
    3006260740-2011-00132
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    March 30, 2011
    Report Date
    May 2, 2011
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K070996
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A CHR REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    ON (B)(6) 2011, AN ATTEMPTED PICC PLACEMENT AT THE BEDSIDE WAS UNSUCCESSFUL. ON (B)(6) 2011, PT WAS ADMITTED WITH SYMPTOMS OF SEPSIS AND A WIRE WAS IDENTIFIED ON IMAGING AND REMOVED VIA INTERVENTIONAL RADIOLOGY. IT IS APPROX 2 INCHES IN LENGTH AND HAS THE MAGNETIC TIP ON ONE END. AN UNUSED WIRE WAS REVIEWED AND REVEALED SEVERAL SERPENTINE LIKE AREAS WHERE THE WIRE LOOKS AS THOUGH IT COULD BREAK IF BENT OR JAMMED. THE PT HAD A PREVIOUS IMPLANTED PORT IN THE SAME VESSEL AND MAY HAVE HAD SCAR TISSUE THAT PREVENTED THE PICC FROM PASSING CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4 FR. S/L POWERPICC - NURSING FULL (TLS) LJS C.R. BARD, INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention