BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GROSHONG 3 FR SINGLE LUMEN, FULL TRAY WITH MI

    MDR report key: 2993841 · Received March 4, 2013

    Report

    Report Number
    3006260740-2013-00097
    Event Type
    Injury
    Date Received
    March 4, 2013
    Date of Event
    January 29, 2013
    Report Date
    February 8, 2013
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K926331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    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 REWI1043 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    SITE OF PLACEMENT: RIGHT BASILIC. NO DIFFICULTY WITH INSERTION. NO PROBLEM WITH THE CATHETER ITSELF. THE WIRE CAUSED THE REACTION IN THE CHILD. PT INJURY INVOLVED, SIMPLE INSERTION, WELL SEDATED CHILD. INSERTION WENT EASY. WIRE WAS PULLED, CATHETER WAS TRIMMED AND THEN FLUSHED WITH 10 ML SALINE AT WHICH POINT THE CHILD STARTED COUGHING AND TURNED BRIGHT RED. O2 SATS WENT DOWN TO 79, BLOOD PRESSURE WENT DOWN, HEART RATE WENT UP. THIS PERSISTED FOR 8 MINUTES. THERE WAS A POTENTIAL FOR SERIOUS INJURY IF THE PT HAD NOT STARTED BREATHING AGAIN. LINE WAS FLUSHED BEFORE INSERTION WITH 10 ML SALINE PER LUMEN PRIOR TO INSERTION, AND 10 ML AFTER PLACEMENT. SOLUTIONS USED TO CLEAN THE CATHETER: CHG PRIOR TO INSERTION. SALINE USED AFTER INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91562 GROSHONG 3 FR SINGLE LUMEN, FULL TRAY WITH MI LJS C. R. BARD INC. (BASD) REWI1043

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention