BEUDAMED
    FDA Adverse Event Summary report: N

    POWERPICC SOLO 6 FR TL CATHETER, MAXIMAL BARRIER TRAY WITH

    MDR report key: 1772234 · Received July 22, 2010

    Report

    Report Number
    3006260740-2010-00201
    Date Received
    July 22, 2010
    Date of Event
    July 7, 2010
    Report Date
    July 13, 2010
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K0702230
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PT WAS GETTING A PICC LINE FOR TPN - HIS DIAGNOSIS ON ADMISSION WAS SUBDURAL HEMATOMA. DATE PT WAS UP IN THE CHAIR PRIOR TO PROCEDURE, WAS A LITTLE CONFUSED BUT ABLE TO MOVE ABOUT THE ROOM UNDER HIS OWN STRENGTH. DURING THE PROCEDURE, HE KEPT ASKING QUESTIONS AND IT WAS APPARENT HE WAS CONFUSED BUT PLEASANT. IMMEDIATELY AFTER PLACING LINE, HE TOLD ME HE FELT SOB, I LOOKED OVER AT HIM AND HIS WHOLE TRUNK, NECK AND FACE WERE FLUSHED AND I CALLED FOR HELP, WHICH CAME IN IMMEDIATELY AS HE WAS IN THE SICU. I TOLD THEM I SUSPECTED AN ALLERGIC REACTION AND DEXAMETHASONE IVP WAS IMMEDIATELY GIVEN AND AT THE SAME TIME, I WAS WASHING TINTED CHLORAPREP OFF HIS ARM. HIS EPISODE ABORTED QUICKLY AND HE DID NOT REQUIRE ANY FURTHER INTERVENTION. HIS PICC LINE IS STILL IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERPICC SOLO 6 FR TL CATHETER, MAXIMAL BARRIER TRAY WITH LJS C. R. BARD INC. (BASD) REUD0670

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention TPN