BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERPICC 5F DUAL-LUMEN POLYURETHANE CATHETER RADIOLOGY

    MDR report key: 3223843 · Received July 10, 2013

    Report

    Report Number
    3006260740-2013-00337
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    June 16, 2013
    Report Date
    June 21, 2013
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K051672
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. AS THE DEVICE WAS DISCARDED AFTER THE EVENT OCCURRED. A LOT HISTORY REVIEW (LHR) OF REWE0456 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "PATIENT HAD A POWER-PICC INSERTED AT HOSPITAL IN (B)(6) 2013. THE POWER-PICC WAS REMOVED IN AMBULATORY CARE IN (B)(6) 2013. PATIENT HAD OTHER HEALTH PROBLEMS AND HAD A FOLLOW UP ULTRASOUND AT ON (B)(6) 2013, WHEN THEY NOTICED A 3CM SEGMENT OF THE POWER-PICC IN THE AXILLARY VEIN. THIS WAS REMOVED AS THE PATIENT WAS THERE FOR OTHER PROCEDURES. THE 3CM SEGMENT OF CATHETER FOUND IN PATIENT'S AXILLARY VEIN ON FOLLOW UP ULTRASOUND POST REMOVAL. PICC LINE WAS INSERTED IN RADIOLOGY DEPARTMENT ON (B)(6) 2013. PICC WAS REMOVED IN AMBULATORY CARE UNIT ON (B)(6) /2013. ULTRASOUND WAS CONDUCTED ON (B)(6) 2013. PATIENT WAS REQUIRED TO HAVE RETAIN SEGMENT SURGICALLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317620 POWERPICC 5F DUAL-LUMEN POLYURETHANE CATHETER RADIOLOGY LJS C. R. BARD INC. (BASD) REWE0456

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention