BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN EXTERNAL DRAINAGE SYSTEM III

    MDR report key: 3232908 · Received July 18, 2013

    Report

    Report Number
    1226348-2013-21437
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 21, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    PK954021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS PROVIDED TO THE AFFILIATE: AS NOTICED IN THE PULL TEST (OF THE COMPLAINT (B)(4)) THAT WAS DONE, THE RESULTS WERE WELL OVER THE SPECIFICATION OF 13.3N. (12 N ON THE INVESTIGATION REPORT WAS AN TYPO ERROR THIS SHOW HAVE READ 13.3 N). THE INCOMING INSPECTION PULL TEST ON THE LOT TUBING USED FOR THE FINISHED PRODUCT WAS FOUND TO BE CLEARLY SUPERIOR THAN THE 13.3 N SPECIFIED. THEORIES ON THE 13.3 N TENSILE SPECIFICATION ON THE EDS3 TUBING. VARIOUS ISO SPECIFICATIONS THAT WE HAVE FOUND THAT RELATE TO THE EDS3 TUBE ASSEMBLY. ACCORDING TO REGULATORY, THE ORIGINAL EDS SYSTEM WAS SUBMITTED USING THE ISO 7197 (3RD EDITION) AS THE STANDARD TO MEET. WITH THAT IN MIND, PERHAPS THE DESIGN TEAM BACK IN THE 1990¿S FIGURED A 13.3 N (3.0 LBS) SPECIFICATION WOULD BE ADEQUATE BASED ON A 5N (1.12 LBS) REQUIREMENT. WE ARE CONSIDERING CHANGING THE SPECIFICATION TO 15N FOR 15S AFTER 5 DAYS OF HYDRATION. THIS IS STILL BEING WORKED ON HERE IN A PROJECT. ¿ ISO 7197 (3RD EDITION 2006-06 AND NEWER). O 10% ELONGATION OR A MAXIMUM FORCE OF 5N (1.12 LBS) WHICHEVER COMES FIRST OVER 100,000 CYCLES (1 +/-0.2 HZ).

    Additional Manufacturer Narrative · 1

    THE EDS III WAS VISUALLY INSPECTED, AND CONFIRMED THAT THE TUBING HAS COME AWAY FROM THE NEEDLESS PORT. IT WAS NOT DETERMINED AS TO HOW THIS HAPPENED; GLUE TRACES WERE NOTED ON THE TUBING AND ON THE NEEDLESS PORT. THE CURRENT QUALITY INSPECTION FOR THESE ASSEMBLIES IS ESTABLISHED TO 100% TEST FOR LEAK AND BLOCKAGE. THE NEW EDS III WAS SUBJECTED TO A PULL TEST ON THE CONNECTORS AND TUBING, THE EDS III PASSED THE TESTS. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE EDS III CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. AT THIS TIME, THE COMPLAINT IS CONSIDERED TO BE CLOSED.

    Description of Event or Problem · 1

    2/4/2014 ADDITIONAL INFORMATION FROM THE CUSTOMER STATED: FOR THE ABOVE COMPLAINT, I HAVE FURTHER QUESTIONS FROM THE HOSPITAL AUTHORITY. THE REPORT MENTION THAT THE TENSILE STRENGTH OF LESS THAN 12 N. ACCORDING TO ISO STANDARD, THE INFUSION SET, EXCLUDING PROTECTIVE CAPS, SHALL WITHSTAND A STATIC TENSILE FORCE OF NOT LESS THAN 15 N FOR 15 S". COULD YOU KINDLY ADVISE WHAT STANDARD WAS ADOPTED IN FOR THIS PRODUCT AS IT IS 3N LESS THAN ISO STANDARD OF INFUSION SETS.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED DURING PATIENT USAGE, THERE WAS A SHARP BREAKAGE BETWEEN THE CONNECTOR AND TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336248 CODMAN EXTERNAL DRAINAGE SYSTEM III SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. CPBDBY

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention