BEUDAMED
    FDA Adverse Event Injury Summary report: N

    55 CM 5 FR SL POWERGROSHONG FULL TRAY WITH TLS

    MDR report key: 1914196 · Received December 1, 2010

    Report

    Report Number
    3006260740-2010-00356
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    November 20, 2010
    Report Date
    November 29, 2010
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K063848
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A 5 FR DOUBLE LUMEN POWERPICC WAS PLACED INTO A DIFFERENT PT LOT REUH1120 AND THE PT ALSO EXPERIENCED SHORTNESS OF BREATH, CHEST PAIN AND PANIC TYPE REACTION WHEN THE SALINE WAS FLUSHED INTO THE LINE. RAPID RESPONSE WAS CALLED. UNABLE TO VERIFY CHANGES IN VITAL SIGNS BECAUSE THIS WAS AN "OUTPATIENT" PLACEMENT AND VITALS WERE NOT CHECKED PRIOR TO PLACEMENT. SYMPTOMS INCLUDED CHEST PAIN, BACK PAIN, PANIC, TINGLING IN HANDS, PAIN IN LEGS, METALIC TASTE IN MOUTH, SEEING SPOTS, SHORTNESS OF BREATH AND CHEST PAIN. REACTION OCCURRED PRIOR TO DRESSING, PRIOR TO CLEANING, AND AFTER STYLET WAS REMOVED, DURING THE FLUSHING OF THE LINE WITH SALINE FROM THE BAS KIT. RN DOES "RAPID" FLUSH OF SALINE TO CLEAR BLOOD FROM THE LINE AFTER CHECKING ASPIRATION. REACTION RESOLVED WITHIN A FEW MINUTES AND PICC LINE WAS LEFT IN PT. PLACEMENT WAS VERIFIED TO BE IN THE SVC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 55 CM 5 FR SL POWERGROSHONG FULL TRAY WITH TLS LJS C. R. BARD INC. (BASD) REUH1120

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention