BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5 FR DL POWERPICC SOLO CATHETER, BASIC WITH TLS

    MDR report key: 2298515 · Received October 12, 2011

    Report

    Report Number
    3006260740-2011-00313
    Event Type
    Injury
    Date Received
    October 12, 2011
    Date of Event
    July 12, 2011
    Report Date
    September 29, 2011
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K072230
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVAL, AS THE DEVICE WAS DISCARDED AFTER REMOVAL. A LOT HISTORY REVIEW (LHR) OR REVD0917 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INSERTION, TIP INITIALLY MALPOSITIONED TO IJ THEN AZYGOUS, HOB ELEVATED AND PT IMMEDIATELY CLUTCHED HIS CHEST AND STARTED MOANING AND WAVING THAT SOMETHING WAS WRONG, THEN POINTED TO HIS HEAD THAT HE WAS DIZZY. FACE PALE AND ARMS FLUSHED, PT LOST CONSCIOUSNESS FOR APPROXIMATELY ONE MINUTE. INITIAL BP 130/90 (DIFFICULT TO GET READING) P77, O2 SAT 96% (ON O2), IT TOOK SEVERAL MINUTES FOR SYMPTOMS TO RESOLVE, HOWEVER, PT CONTINUED TO HAVE INCREASED HR OF 140-144. ATTENDING RESIDENT CALLED AND ASSESSED THE PT AND FELT MOSTLY RELATED TO PT'S CONDITION WITH SOME PICC INVOLVEMENT (IE VASOVAGAL). PT ACCOMPANIED BACK TO UNIT AND CXRAY DONE. TIP PLACEMENT DISTAL SVC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5 FR DL POWERPICC SOLO CATHETER, BASIC WITH TLS LJS C. R. BARD INC. (BASD) REVD0917

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention