BEUDAMED
    FDA Adverse Event Injury Summary report: N

    19CM STRAIGHT HEMOSPLIT MI KIT WITH AIRGUARD

    MDR report key: 2922278 · Received January 11, 2013

    Report

    Report Number
    3006260740-2013-00029
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 25, 2012
    Report Date
    December 26, 2012
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    MSD
    PMA / PMN Number
    K030020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF A DETACHED SURECUFF AND HEAT SLEEVE IS CONFIRMED. GROSS AND MICROSCOPIC EXAMINATIONS CONFIRM A COMPLETE SEPARATION OF THE SURECUFF/HEAT SLEEVE FROM THE CATHETER. THE DETACHED HEAT SLEEVE/SURECUFF WAS NOT RETURNED FOR EVALUATION. ACCORDING TO THE NOTES CONTAINED INT EH COMPLAINT INCIDENT REPORT THE COMPLAINANT INDICATED THE HEAT SLEEVE/SURECUFF STILL RESIDES IN THE PT. AT THIS TIME. THE MECHANISM OF DAMAGE IS UNDETERMINED. A LOT HISTORY REVIEW (LHR) OF REVG1020 SHOWED SEVEN OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. (391593, 410159, 416309, 416307, 417748, 422176, 423915).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (B)(6) 2012, THE DOCTOR PLACED A LONG TERM CATHETER VIA RIGHT INTERNAL JUGULAR VEIN. (B)(6) 2012, THE PT FOUND THE CATHETER OUT OF THE CATHETER 2CM WHEN HE WAS HEMODIALYSIS AT HOSPITAL. THE DOCTOR HAS TO EXTRACTION THE CATHETER AND PLACED A NEW CATHETER FROM RIGHT IJ VEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17921 19CM STRAIGHT HEMOSPLIT MI KIT WITH AIRGUARD MSD C.R. BARD, INC. (BASD) REVG1020

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention