BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC KIT: 2-LUMEN 8 FR X 20 CM

    MDR report key: 1913040 · Received June 11, 2010

    Report

    Report Number
    1036844-2010-00040
    Event Type
    Malfunction
    Date Received
    June 11, 2010
    Date of Event
    February 24, 2009
    Report Date
    March 3, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT WAS INITIALLY EVALUATED AND DETERMINED TO BE NON-REPORTABLE. THE RETURNED DEVICE WAS EVALUATED AND THE EVENT WAS DETERMINED TO BE A RESULT OF A PRODUCT MALFUNCTION, THEREFORE, IT IS REPORTABLE. EVALUATION: TWO SWG'S AND ONE INTRODUCER NEEDLE WERE RETURNED FOR EVALUATION. THE RETURNED COMPONENTS WERE VISUALLY EXAMINED. THE NEEDLE WAS RETURNED WITH ONE SWG PROTRUDING FROM BOTH ENDS. J-END OF THE SWG EXTENDED FROM DISTAL TIP OF THE NEEDLE & STRAIGHT END OF THE SWG EXTENDED FROM HUB. SWG WAS IN ONE PIECE CONNECTED BY THE COIL WIRE; CORE WIRE WAS BROKEN. J-BEND APPEARED TYPICAL, BUT BETWEEN J-BEND & NEEDLE BEVEL, THE CORE WIRE BROKE & COIL WIRE UNRAVELED. SECOND WIRE EXHIBITED ONE KINK AT 2CM FROM J-TIP & WAS NOT UNRAVELED. THE WELDS ON BOTH SWG'S WERE OBSERVED TO BE INTACT. NO NICKS OR CUTS FROM THE NEEDLE WERE OBSERVED ON EITHER RETURNED SWG; BOTH SWG'S MET SPECIFICATION. THE RETURNED NEEDLE APPEARED TYPICAL & ALSO MET SPECIFICATION. A FUNCTIONAL TEST WAS PERFORMED BY INSERTING BOTH THE STRAIGHT END & THE J-TIP OF THE RETURNED KINKED SWG INTO NEEDLE HUB. IN BOTH CASES, THE SWG PASSED THROUGH THE NEEDLE FREELY. THE PRODUCTS INSTRUCTIONS FOR USE (IFU), (B)(4), WARNS ABOUT POSSIBLE DAMAGE TO THE SWG IF THE GUIDEWIRE IS WITHDRAWN AGAINST THE NEEDLE BEVEL & IF EXCESSIVE FORCE IS USED IN THE REMOVAL PROCESS. THE IFU ALSO SUGGESTS USING CARE & PROVIDES INSTRUCTIONS WHEN REMOVING SWG IF RESISTANCE IS ENCOUNTERED. THE INVESTIGATION FOUND NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. THE REPORTED EVENT WAS CONFIRMED, HOWEVER, THE POTENTIAL CAUSE OF THE COMPLAINT COULD NOT BE DETERMINED. (B)(4). ADDITIONAL OCCURRENCES ARE DOCUMENTED AS MDR #1036844-2009-00206. UNTIL (B)(6) 2009, MULTIPLE OCCURRENCES WERE REPORTED ON A SINGLE MDR. THEY ARE NOW REPORTED AS INDIVIDUAL EVENTS. ALL MULTIPLE OCCURRENCES FROM (B)(6) 2009 THROUGH (B)(6) 2009 ARE BEING REMEDIATED TO INCLUDE THE CORRECT NUMBER OF COMPLAINTS, MDRS, VIGILANCE, AND (B)(4) REPORTS. PLEASE REFER TO THE MDR FOR THE ORIGINAL COMPLAINT REFERENCED ABOVE FOR THE FOLLOW-UP FOR THIS MDR.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINICIAN THAT THEY HAD AN INSTANCE WHERE THE SPRING WIRE GUIDE (SWG) BECAME STUCK ON THE TIP OF THE NEEDLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC KIT: 2-LUMEN 8 FR X 20 CM ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTL., INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK