BEUDAMED
    FDA Adverse Event Other Summary report: N

    2FR SL V-CATH PICC MINI

    MDR report key: 2392315 · Received December 14, 2011

    Report

    Report Number
    2925153-2011-00016
    Event Type
    Other
    Date Received
    December 14, 2011
    Date of Event
    September 22, 2011
    Report Date
    December 12, 2011
    Manufacturer
    NEO MEDICAL
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS ASSESSED AND DETERMINED TO BE AN MDR REPORT BASED ON OUR MDR REPORTING CRITERIA. THE REPORT PROVIDED BY MHRS ADVERSE INCIDENT REPORT INDICATES THAT THE DEVICE IN QUESTION HAS BEEN DISPOSED OF. NO PRODUCT LOT NUMBER WAS PROVIDED AND IS NOTED BLANK ON THE REPORT. F/U REPORT WILL BE PROVIDED UPON THE COMPLETION OF THE COMPLAINT INVESTIGATION ANALYSIS ((B)(4) IS COMPLETED).

    Description of Event or Problem · 1

    AS STATED BY REPORT FROM (B)(6): PRESSURES MONITORED ON THE PTS LONG LINE WERE SLOWLY INCREASING. PRESSURES CONTINUED TO RISE, ATTEMPTED TO FLUSH WITH 0.9% SALINE BUT EXTREMELY DIFFICULT AND RED MARK APPEARED ALONG LENGTH OF PT'S LEG. SURGICAL REGISTRAR CALLED AND FLUIDS DISCONTINUED APART FROM MORPHINE INFUSION. PERIPHERAL LINE INSERTED AND WHEN SETS CHANGED OVER, LONG PICC WAS FOUND SNAPPED IN PT'S BED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2FR SL V-CATH PICC MINI 2FR SL V-CATH PICC DQY NEO MEDICAL 355-75 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1