BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2FR S/L PER-Q-CAATH PLUS A SILICONE PERCUTANEOUS CVC W/EXC

    MDR report key: 2993855 · Received March 4, 2013

    Report

    Report Number
    3006260740-2013-00088
    Event Type
    Injury
    Date Received
    March 4, 2013
    Date of Event
    January 28, 2013
    Report Date
    February 5, 2013
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K954104
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR AT THIS TIME FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF REVL0649 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE CATHETER WAS INSERTED IN (B)(6) 2013, 15:30 PM WITHOUT DIFFICULTY. AFTER INFUSION OF ANTIBIOTIC IT WAS OBSERVED THAT THE CATHETER WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91494 2FR S/L PER-Q-CAATH PLUS A SILICONE PERCUTANEOUS CVC W/EXC LJS C. R. BARD INC. (BASD) REVL0649

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention