BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERPICC SOLO CATHETER WITH SHERLOCK 3CG (TPS) STYLET 5

    MDR report key: 3409183 · Received October 8, 2013

    Report

    Report Number
    3006260740-2013-00444
    Event Type
    Injury
    Date Received
    October 8, 2013
    Report Date
    September 30, 2013
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K091324
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVAL, AS THE DEVICE WAS DISCARDED AFTER THE EVENT OCCURRED. A LOT HISTORY REVIEW (LHR) OF REXF0818 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    "SYMPTOMS STARTED, WITH SEVERAL EPISODES OF EMESIS. PT WAS BROUGHT IN FOR SHORTNESS OF BREATH, TACHYCARDIA AND HYPOXIA WITH DESATURATION TO 80% ON ROOM AIR, PER PARAMEDICS. ARRIVED TO FIND PT TACHYCARDIC MID-120S, TACHYPNEIC TO 40S, ON 50% OXYGEN BY BIPAP" (EXCERPTED FROM THE H&P). PT IS A PARAPLEGIC WITH A VERY HIGH DIAPHRAGM. CALLED TO THE ER WHERE A 5FR DOUBLE LUMEN SOLO PICC TOTAL LENGTH OF 40CM TO THE RIGHT BASILIC VEIN WITH POSITIVE TIP CONFIRMATION AT THE CAJ FROM THE PT SIGNAL WAS PLACED. THE AM PCXR SHOWED THE TIP MALPOSITIONED UP INTO THE RIGHT IJ VEIN. RN REPLACED THE PICC WITH ANOTHER 5FR DOUBLE LUMEN POWER SOLO PICC TOTAL LENGTH OF 40CM TO THE RIGHT BASILIC VEIN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508260 POWERPICC SOLO CATHETER WITH SHERLOCK 3CG (TPS) STYLET 5 LJS C. R. BARD INC. (BASD) REXF0818

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention