BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 4-LUMEN 8.5FR X 20CM

    MDR report key: 2021403 · Received February 8, 2011

    Report

    Report Number
    3006425876-2011-00011
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 8, 2011
    Report Date
    February 4, 2011
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    REFERENCE MDR #3006425876-2011-00010 FOR THE FIRST EVENT INVOLVING THE SAME PATIENT. IT WAS REPORTED THAT THE PATIENT WAS A (B)(6) FEMALE BEING RESUSCITATED WITH ENDOCARDITIS. THE SECOND KIT WAS OPENED AND TESTED PRIOR TO USE. DURING PRE-TEST, THE 18GA X 6.35 CM NEEDLE WOULD NOT ALLOW PASSAGE OF THE SPRING WIRE GUIDE (SWG). THE DEVICE WAS NOT USED AND ANOTHER KIT, (B)(4), WAS OPENED AND INSERTED SUCCESSFULLY. A DELAY OF A FEW MINUTES WAS NOTED. THERE WAS NO REPORTED PATIENT DEATH, INJURY OR COMPLICATIONS NOTED. THE PATIENT OUTCOME IS NOTED AS "FINE." ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2011 FROM THE (B)(6) COORDINATOR MANAGER INDICATED THAT THE DILATOR DID NOT FLOW WELL OVER THE SWG. THE INTERVENTION REQUIRED WAS TO INSERT ANOTHER CATHETER AND A DELAY OF 15 MINUTES OCCURRED. THE EVENT WAS NOT A PROBLEM WITH THE SWG PASSING THROUGH THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC SET: 4-LUMEN 8.5FR X 20CM ADULT MULTI-LUMEN CATHETER PRODUCTS DQY ARROW INTERNATIONAL INC ZF0111454

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR