BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 FR. S/L POLY PERQCATH UPFT WITH MI AND TLS

    MDR report key: 1545052 · Received November 12, 2009

    Report

    Report Number
    3006260740-2009-00372
    Event Type
    Malfunction
    Date Received
    November 12, 2009
    Report Date
    October 19, 2009
    Manufacturer
    C.R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K063240
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PT WAS ORDERED TO HAVE VERSED PRIOR TO PICC PLACEMENT. VERSED 2.12 MG GIVEN. AFTER PICC PLACEMENT, PT WAS NOTED TO BE JITTERY. INITIALLY TOO IRRITABLE TO TAKE PO. O2 SATS 97%, P=180, B/P 83/47. PEW SCORE 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3 FR. S/L POLY PERQCATH UPFT WITH MI AND TLS LJS C.R. BARD INC. (BASD) RETC1123

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention