BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4 FR S/L POWERPICC SOLO FULL TRAY

    MDR report key: 3874620 · Received April 24, 2014

    Report

    Report Number
    3006260740-2014-00211
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 26, 2014
    Report Date
    March 31, 2014
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K091324
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER HAS REC'D THE SAMPLE AND WILL BE EVALUATED. RESULTS ARE EXPECTED SOON. A LOT HISTORY REVIEW (LHR) OF REXK0145 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    A SHORT TIME AFTER PLACING THE PICC ON (B)(6) 2014, THE INFUSION NURSE CALLED AND SAID SHE WAS HAVING DIFFICULTY FLUSHING OR ASPIRATING THE PICC LINE. THE NURSE WHO INSERTED THE PICC THOUGHT THAT IT WAS POSITIONAL AND WHEN THE INFUSION NURSE TRIED TO REPOSITION PATIENT THE LINE WORKED BETTER. ON (B)(6) 2014, I REC'D A CALL FROM THE INFUSION NURSE AGAIN STATING THAT THE PICC LINE HAD INFILTRATED AND THEY HAD TAKEN IT OUT. PATIENT WAS SEEN BY THE PICC TEAM ON (B)(6) 2014 AND BROUGHT THE DISCONTINUED PICC LINE WITH HER. IT WAS NOTED THAT THERE WAS A BREAK IN THE PICC LINE IN TWO PLACES. ONE BREAK WAS AT THE 11CM MARK AND THE OTHER WAS AT THE 12CM MARK. NOT SURE HOW LONG THE BREAKS WERE IN THE SINCE PATIENT COMPLAINED OF PROBLEMS WITH THE LINE SINCE INSERTION. THERE WAS NO HARM TO THE PATIENT, ALTHOUGH IT DID NOT CAUSE AN INFILTRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248159 4 FR S/L POWERPICC SOLO FULL TRAY LJS C.R. BARD, INC. (BASD) REXK0145

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention