BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 2-LUMEN 5 FR X 8 CM

    MDR report key: 1884223 · Received June 11, 2010

    Report

    Report Number
    1036844-2010-00069
    Event Type
    Malfunction
    Date Received
    June 11, 2010
    Date of Event
    May 26, 2009
    Report Date
    March 23, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    FOZ
    PMA / PMN Number
    K900263
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL: ONE CS-25502 CVC SET WAS RETURNED. IT WAS INITIALLY REPORTED THAT PHYSICIAN FELT THAT SPRING WIRE GUIDE (SWG) IN CS-25502 SET WAS TOO SOFT AND THAT IT WAS NOT EVIDENT THAT SETS CONTAIN DIFFERENT SWG'S. IT WAS SUBSEQUENTLY REPORTED THAT ISSUE WAS RELATED TO THE PHYSICIAN'S UNFAMILIARITY WITH TEFLON COATED SWG IN CS-25502 KIT, SINCE COMBINATION OF THE TEFLON COATED SWG AND SURGICAL GLOVES HAD A DIFFERENT FEEL AND MADE IT DIFFICULT TO DETERMINE WHEN SWG PASSED THROUGH NEEDLE TIP AND INTO VESSEL. IT WAS CONFIRMED THAT RETURNED CS-25502 KIT CONTAINED CORRECT SWG. BOTH CS-25502 AND CS-14502 KITS CONTAIN A .53 MM DIAMETER X 45 CM LENGTH SWG WITH A STRAIGHT TIP ON ONE END AND A J-TIP ON THE OTHER END. DIFFERENCE BETWEEN THE TWO WIRES: SWG USED IN CS-25502 SET IS PTFE-COATED AND SWG IN CS-14502 IS NOT. SWG INFO LISTED ON LIDSTOCK AND INFO CONTENTS LABEL FOR CS-25502 KIT DOES INDICATE THAT SWG IS PTFE-COATED. INSTRUCTION BOOKLET PROVIDED WITH CS-25502 SETS CONTAINS A WARNING THAT A PRACTITIONERS MUST BE AWARE OF COMPLICATIONS ASSOCIATED WITH CVC'S INCLUDING HEMATOMA. THE REPORT THAT THE SWG CONTAINED IN THE CS-25502 SET HAS A DIFFERENT FEEL THAN SWG IN CS-14502 SETS WAS CONFIRMED THROUGH A REVIEW OF THE MFG SPECS, AS SWG CONTAINED IN THE CS-25502 SETS HAS A TEFLON COATING. NO SWG DEFECTS OR DEFICIENCIES WERE IDENTIFIED DURING THIS INVESTIGATION. THE POTENTIAL CAUSE OF THIS ISSUE IS DESIGN RELATED BASED ON CUSTOMER'S PREFERENCE FOR THE NON-PTFE COATED SWG. THIS IS ONE OF 3 RECORDS REFLECTING MULTIPLE OCCURRENCES OF MFR CONTROL NO. (B)(4). ADD'L OCCURRENCES ARE DOCUMENTED AS MDR #1036844-2010-00142, 1036844-2010-00070. 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 CANADIAN 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 PHYSICIAN THAT THEY WERE USING THE CS-25502 AS A SUBSTITUTE PRODUCT FOR THE CS-14502. IT WAS NOT EVIDENT THAT THE SET CONTAINED ANOTHER SPRING WIRE GUIDE (SWG). THE PHYSICIAN TOLD THIS SERIES REPRESENTATIVE THAT THE SWG IS TOO SOFT AND CAUSED A STRONG HEMATOMA ON A CHILD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC SET: 2-LUMEN 5 FR X 8 CM ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTL., INC. ZF9014713

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK