BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELSIOR 150 CM 2 TIP

    MDR report key: 3000535 · Received March 12, 2013

    Report

    Report Number
    3008853977-2013-00044
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 27, 2013
    Manufacturer
    BOSTON SCIENTIFIC CORK, LTD
    Product Code
    KRA
    PMA / PMN Number
    K994155
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT THE CATHETER SHAFT WAS BROKEN. IN THE ADDITIONAL INFORMATION IT IS STATED THAT THE DISPENSER HOOP WAS NOT FLUSHED PRIOR TO REMOVE THE CATHETER. THE LABELING STATES: "FLUSH DISPENSER COIL PRIOR TO REMOVAL FROM DISPENSER COIL. ONCE PRODUCT IS HYDRATED DO NOT ALLOW TO DRY, DO NOT REINSERT PRODUCT INTO DISPENSER." THE DEVICE WAS FOUND TO BE BROKEN AFTER IT WAS REMOVED FROM THE DISPENSER HOOP. IT IS PROBABLE THAT THE DEVICE WAS DAMAGED UPON REMOVAL FROM THE HOOP DURING THE PREPARATION AS THE DEVICE WAS NOT FLUSHED. THEREFORE, A PROBABLE ASSIGNABLE CAUSE OF DFU INSTRUCTION NOT FOLLOWED HAS BEEN ASSIGNED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    DURING PREPARATION AFTER THE DEVICE WAS REMOVED FROM THE DISPENSER HOOP, THE CATHETER SHAFT WAS FOUND TO BE BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    DURING PREPARATION AFTER THE DEVICE WAS REMOVED FROM THE DISPENSER HOOP, THE CATHETER SHAFT WAS FOUND TO BE BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103981 EXCELSIOR 150 CM 2 TIP CATHETER, CONTINUOUS FLUSH KRA BOSTON SCIENTIFIC CORK, LTD 15056197

    Patients

    Seq Age Sex Outcome Treatment
    1