BEUDAMED
    FDA Adverse Event Injury Summary report: N

    23 CM 14.5 FR HEMOSTAR STANDARD KIT

    MDR report key: 2121064 · Received June 9, 2011

    Report

    Report Number
    3006260740-2011-00185
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    April 28, 2011
    Report Date
    June 3, 2011
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    MSD
    PMA / PMN Number
    K051748
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF (B)(4) SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CATHETER WAS INSERTED ON (B)(6) 2011 BY A RADIOLOGIST, AFTER THE CATHETER WAS INSERTED IT WAS FINE. ABOUT A WEEK OR SO, THE CATHETER WAS REMOVED IN THE HOSPITAL DUE TO BLEEDING FROM THE A PORT LINE. PT WAS VERY UNPLEASED DUE TO THE FACT HE HAD EXPERIENCED A FAULTY CATHETER TWICE IN SGH PLACEMENT, THE PREVIOUS INCIDENT WAS A CRACK PRESENT AT THE A PORT LINE OF THE TUNNELED DIALYSIS CATHETER. THUS THEY HAD TO DO ANOTHER REPLACEMENT OF CATHETER FOR THE PT ON THE ABOVE MENTIONED DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 23 CM 14.5 FR HEMOSTAR STANDARD KIT MSD C. R. BARD INC. (BASD) REUG1166

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention