BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LUMEN CVC KIT: 3-L 7 FR X 8(20C

    MDR report key: 1884218 · Received June 11, 2010

    Report

    Report Number
    1036844-2010-00082
    Event Type
    Malfunction
    Date Received
    June 11, 2010
    Date of Event
    February 23, 2009
    Report Date
    April 26, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    FOZ
    PMA / PMN Number
    K993691
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL: THE CUSTOMER REPORTED SWG'S FROM 3 KITS UNCOILED, BUT THEY DID NOT RETAIN ANY OF THE WIRES. THE CUSTOMER RETURNED TWELVE SEALED KITS FROM THREE DIFFERENT LOTS. TWO SWG'S FROM EACH OF THE RETURNED LOTS WERE MICROSCOPICALLY EXAMINED. THE WELDS WERE INTACT AND NO SEPARATIONS WERE OBSERVED. ALL SWG'S EXAMINED MET SPECIFICATIONS. THE PRODUCT'S INSTRUCTION BOOKLET WARNS ABOUT POSSIBLE DAMAGE TO THE SWG IF THE WIRE IS WITHDRAWN AGAINST THE NEEDLE BEVEL AND ALSO SUGGESTS USING CARE WHEN REMOVING SWG IF RESISTANCE IS ENCOUNTERED. THE REPORTED COMPLAINT OF SWG UNRAVELLING COULD NOT BE CONFIRMED SINCE THE CUSTOMER DID NOT RETURN THE DAMAGED SWG'S. THE POTENTIAL CAUSE OF THIS ISSUE IS MFG RELATED. THE DEVICE HISTORY RECORD REVIEW FOUND A POTENTIALLY RELEVANT ISSUE AND A NONCONFORMANCE HAS BEEN INITIATED TO FURTHER INVESTIGATE THIS ISSUE. THIS IS ONE OF 4 RECORDS REFLECTING MULTIPLE OCCURRENCES OF (B)(4). ADDITIONAL OCCURRENCES ARE DOCUMENTED AS MDR #1036844-2009-00049, MDR #1036844-2010-00083 MDR #1036844-2010-00084. UNTIL (B)(4) 2009, MULTIPLE OCCURRENCES WERE REPORTED ON A SINGLE MDR. THEY ARE NOW REPORTED AS INDIVIDUAL EVENTS. ALL MULTIPLE OCCURRENCES FROM (B)(4) 2009 THROUGH (B)(4) 2009 ARE BEING REMEDIATED TO INCLUDE THE CORRECT NUMBER OF COMPLAINTS, MDRS, VIGILANCE, AND (B)(6) REPORTS. PLEASE REFER TO THE MDR FOR THE ORIGINAL COMPLAINT REFERENCED ABOVE FOR THE F/U FOR THIS MDR.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINICIAN THAT THE SPRING WIRE GUIDE (SWG) UNCOILED WHILE IN USE. ON (B)(4) 2009, THE SALES REP SPOKE WITH THE CLINICAL NURSE MGR AND WAS TOLD THAT SHE DOES NOT KNOW IF THIS HAPPENED WITH TWO OR THREE KITS. THE PT WAS OBESE AND THE ER PHYSICIAN WAS ATTEMPTING A SUB CLAVIAN PLACEMENT. A TRAUMA SURGEON WAS CALLED IN TO HELP WHEN PLACEMENT BECAME A PROBLEM. REFERENCE MEDWATCH 1036844-2009-00050 FOR SECOND EVENT INVOLVING SAME PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LUMEN CVC KIT: 3-L 7 FR X 8(20C ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTL., INC. RL8057347

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK