BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER PICC SOLO2 CATHETER WITH SHERLOCK 3CG TIP

    MDR report key: 4436522 · Received January 19, 2015

    Report

    Report Number
    3006260740-2015-00025
    Event Type
    Malfunction
    Date Received
    January 19, 2015
    Report Date
    January 5, 2015
    Manufacturer
    BARD ACCESS SYSTEMS INC.
    Product Code
    LJS
    PMA / PMN Number
    K091324
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR, AT THIS TIME, FOR EVAL. A LOT HISTORY REVIEW OF REYC1250 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT FROM THESE LOT NUMBERS.

    Description of Event or Problem · 1

    ON (B)(6) 2015, IT WAS REPORTED A PICC PLACED (B)(6), BLOOD CX DRAWN ON (B)(6) +YEAST (RESULTED (B)(6)). PLACED NEW PICC (IN OTHER ARM) ON (B)(6). REPORTEDLY REMOVED OLD PICC TO CX THE TIP AND FOUND UPON REMOVAL THE CATHETER ALLEGEDLY FILLETED BETWEEN THE 36-39 CM MARK WITH A REPORTED WHITE-ISH RED THROMBUS DISTAL TO BREAK. ENTIRE CATH REMOVED WITHOUT INCIDENT. NO C/O SLUGGISHNESS OR INABILITY TO DRAW BLOOD FROM RN. PT CONFESSED TO PUTTING CRUSHED PILLS IN HIS PICC X2, UNK DATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43416 POWER PICC SOLO2 CATHETER WITH SHERLOCK 3CG TIP LJS BARD ACCESS SYSTEMS INC. REYC1250

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention