BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4 FR S/L GROSHONG NXT REPAIR KIT

    MDR report key: 1251283 · Received December 4, 2008

    Report

    Report Number
    3006260740-2008-00223
    Event Type
    Injury
    Date Received
    December 4, 2008
    Report Date
    November 10, 2008
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K034020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REPAIR WAS PERFORMED ON LEAKING PICC THEN ATTACHED TO 5FU PUMP. IT WAS NOTED LATER THAT THE PICC WAS NOT ATTACHED TO THE CATHETER HUB. THE HUB REMAINED ATTACHED TO THE STATLOCK, AND THE PICC CATHETER HAD MIGRATED INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4 FR S/L GROSHONG NXT REPAIR KIT LJS C. R. BARD INC. (BASD) RESF1134

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention