BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S/L PERC 7 FR 65D

    MDR report key: 1031920 · Received April 17, 2008

    Report

    Report Number
    2523003-2008-00044
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    March 14, 2008
    Report Date
    March 26, 2008
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K831386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS INCONCLUSIVE DUE TO THE NATURE OF THE COMPLAINT. IT WAS REPORTED THAT AFTER THE LINE WAS FLUSHED, THE PT HAD AN UNK REACTION. THE REPORTED INCIDENT CANNOT BE REPLICATED IN THE LAB. NO DEFECTS RELATED TO THE MFG PROCESS WERE FOUND ON THE CATHETER. THE CATHETER WAS IN PLACE FOR 32 DAYS BEFORE THE PT HAD THE REACTION. THE CAUSE OF THE ALLERGIC REACTION IS UNK. A CHR OF LOT #RERK0398 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT.

    Description of Event or Problem · 1

    AFTER THE LINE WAS FLUSHED THE PT HAD AN UNK REACTION. THE FAMILY QUESTIONED WHETHER THE LINE WAS DEFECTIVE AND REQUESTED THE LINE BE REMOVED. THE COMPLAINANT WILL GET MORE INFO ABOUT THE PT REACTION TO SEE IF THERE WAS SWELLING OR IF IT WAS AN ALLERGIC REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S/L PERC 7 FR 65D LJS C.R. BARD, INC. (BASD) RERK0398

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention