BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2113572 · Received June 1, 2011

    Report

    Report Number
    3006260740-2011-00158
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 27, 2011
    Manufacturer
    C. R. BARD, INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K070996
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVAL. AN LHR OF (B)(4) SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IMMEDIATELY AFTER THE PICC WAS INSERTED AND THE LUMEN WAS FLUSHED WITH NORMAL SALINE 10ML THE PT C/O HIS EARS FEELING FLUSHED, THEN PT FACE AND THE FLUSH THEN MOVED DOWN THE BODY. THE SYMPTOMS PROGRESSED TO FEELING NAUSEA, CHILLS AND FAINT. PICC WAS PULLED BACK 2CM AND DRESSED. SAT PT UP IN BED AND PLACED A NASAL CANNULA ON HIM WITH 5ML OF O2. CALLED THE FLOOR NURSE AND SHE TOOK THE PT'S BP WHICH WAS IN 50'S. EKG SHOWED SOME TACHYCARDIA BUT NO OTHER CHANGES. PT DID BECOME UNCONSCIOUS FOR SEVERAL SECONDS BUT THEN RESPONDED TO VERBAL STIMULATION. PT DID VOMIT TOO. PT WAS INCONTINENT OF URINE ALSO. THE WHOLE INCIDENT LASTED ABOUT 30 MIN FROM BEGINNING TO THE END. PHYSICIANS WERE INVOLVED TOO.

    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) REVB0988

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention