BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL HOSE

    MDR report key: 446289 · Received March 3, 2003

    Report

    Report Number
    MW1027709
    Event Type
    Malfunction
    Date Received
    March 3, 2003
    Date of Event
    February 7, 2003
    Report Date
    March 3, 2003
    Manufacturer
    LINVATEC
    Product Code
    HSZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AIR HOSE EXPLODED DURING SURGICAL PROCEDURE AND PIECES OF THE RUBBER HOSE LANDED IN THE OPERATIVE SITE CREATING POTENTIAL FOR WOUND INFECTION AND/OR RETAINED FOREIGN BODY.

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM MFR 4-4-03: CATALOG NUMBER IS 00-5052-010-00 UNIVERSAL HOSE, 10 FOOT. LINVATEC RECEIVED A REPORT ON 02/07/03 REGARDING AN ALLEGED 00-5052-010-00 UNIVERSAL HOSE. UPON FURTHER ANALYSIS OF THE SERIAL NUMBER REPORTED TO LINVATEC BY THE HOSPITAL REPORTER, THIS IS NOT A RECOGNIZED LINVATEC SERIAL NUMBER FOR THE 00-5052-010-00 UNIVERSAL HOSE. THE HOSPITAL WAS ADVISED THAT ALL NEW 00-5052-010-00 UNIVERSAL HOSES ARE DATED CODED WITH THE MONTH AND YEAR OF MANUFACTURE. EXAMPLE: APR 03. FOR ANY 00-5052-010-00 UNIVERSAL HOSE THAT IS RETURNED AND REPAIRED BY LINVATEC, THE CURRENT MONTH, YEAR AND THE LETTER "S", DESIGNATING SERVICE, IS PERMANENTLY ETCHED AT THE END OF THE DATED CODE ON THE METAL CONNECTOR. EXAMPLE: APR 03S. THIS PARTICULAR HOSE HAS NOT BEEN RETURNED TO LINVATEC FOR INVESTIGATION OR SERVICE. IT IS SUSPECTED THAT THIS HOSE HAS BEEN SERVICED BY A THIRD PARTY SOURCE (NAME UNKNOWN) AND APPLIED. HOSPITAL REPORTER ADMITTED THAT THEY WERE UNSURE OF WHO MAY HAVE REPAIRED THIS PARTICULAR HOSE. LINVATEC ADVISED THE HOSPITAL THAT THERE IS NO THIRD PARTY SOURCE APPROVED FOR THE REPAIR OF UNIVERSAL HOSES. LINVATEC DOES NOT CONSIDER THIS A REPORTABLE EVENT. FROM THE INITIAL COMMUNICATIONS WITH THE HOSPITAL, IT WAS REPORTED THERE WAS NO INJURY. THE HOSPITAL REPORTER INDICATED TO LINVATEC THAT ALTHOUGH ALLEGED PIECES OF THE HOSE WERE EXPOSED TO THE INCISION SITE, THE PIECES WERE REMOVED AND THGE INCISION WAS IRRIGATED. LINVATEC WAS ADVISED THAT THE HOSE BWAS REPLACED AND THE PROCEDURE COMPLETED WITHOUT INCIDENT. HOSPITAL REPORTER STATED TO LINVATEC THAT NO STAFF OR PT WAS INJURED AND THE HOSE WAS LATER CULTURED AND NO FINDINGS WERE NOTED. LINVATEC CANNOT DETERMINE THAT THIS PARTICULAR HOSE HAS MALFUNCTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL HOSE AIR HOSE HSZ LINVATEC 5052-010 *

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR