BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4 FR. S/L POWERPICC - NURSING FULL TRAY WITH MI, SHERLOCK TLS

    MDR report key: 1772221 · Received July 22, 2010

    Report

    Report Number
    3006260740-2010-00208
    Event Type
    Injury
    Date Received
    July 22, 2010
    Date of Event
    January 6, 2010
    Report Date
    July 12, 2010
    Manufacturer
    C. R. BARD, INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K070996
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING INSERTION OF PICC LINE, PT HAD THE FOLLOWING SYMPTOM, CHEST PRESSURE, FEELING HOT, FACIAL FLUSHING. THE SYMPTOMS HAD BEEN RESOLVED AFTER 5 MINUTES. NO TREATMENT RENDERED. OUTCOME OF PICC LINE: PICC LINE REMAINED INSITU FOR 22 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4 FR. S/L POWERPICC - NURSING FULL TRAY WITH MI, SHERLOCK TLS LJS C. R. BARD, INC. (BASD) RETK0042

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention