BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4FR S/L POWER PICC - NURSING FULL TRAY WITH MI, SHERLOCK TLS

    MDR report key: 1837241 · Received September 7, 2010

    Report

    Report Number
    3006260740-2010-00263
    Event Type
    Injury
    Date Received
    September 7, 2010
    Date of Event
    August 16, 2010
    Report Date
    August 17, 2010
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K070996
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER AT THIS TIME FOR EVALUATION. A CHR REVIEW SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT FILE(S) FROM THIS LOT.

    Description of Event or Problem · 1

    A PT WHO HAD A PREVIOUS REACTION IN JULY, NEEDED TO HAVE THE PICC REPLACED SO, WE TOOK THE PRECAUTION OF GETTING A BENADRYL 50 MG PO PREMEDICATION ORDER. PT TOLERATED THE PROCEDURE WELL UP UNTIL THE DRESSING WAS BEING APPLIED AND THEN PT STARTED TO COMPLAIN OF CHEST PRESSURE AND SOB. THE STAFF NOTED THE FACIAL FLUSHING, GAVE PT O2 AND CHECKED VITAL SIGNS. PT BP ROSE SLIGHTLY BUT ALL WAS BACK TO NORMAL IN UNDER 10 MINUTES. THE PICC WAS LEFT IN PLACE AND PT WAS DISCHARGED TO HOME. THIS WAS PT'S 3RD PICC SINCE MAY. PT HAD NO REACTION WITH THE FIRST, SEVERE REACTION WITH THE SECOND AND MILD REACTION WITH THE 3RD, BUT AGAIN WE PRE-MEDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4FR S/L POWER PICC - NURSING FULL TRAY WITH MI, SHERLOCK TLS LJS C. R. BARD INC. (BASD) REUE0664

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention