BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DPS PRESSURE MONITORING KIT W/ ANTI SHUNT

    MDR report key: 1012708 · Received March 12, 2008

    Report

    Report Number
    1526863-2008-00009
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Report Date
    February 19, 2008
    Manufacturer
    SMITHS MEDICAL
    Product Code
    DRS
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBASSEMBLY IN QUESTION IS A560 AND IS MANUFACTURED BY SMITHS MEDICAL ASD. THIS ASSEMBLY IS INCORPORATED INTO THE FINISHED PROD BY SMITHS MEDICAL INTL IN ANOTHER COUNTRY. THE FINISHED PROD IS FURTHER ASSEMBLED, PACKAGED AND STERILIZED BY ANOTHER COUNTRY'S MFR. A560 SUBASSEMBLIES WERE RECEIVED - ONE WITH A TUBING DISCONNECTION AT THE MALE LUER LOCK (MLL) AND THE SECOND WITH A TUBING DISCONNECTION AT THE FEMALE LUER LOCK (FLL) THAT HAD BEEN BONDED TO THE HANDLE OF THE STOPCOCK. THE SOLVENT RING ON THE TUBING FROM BOTH COMPONENTS SHOWED THE TUBING HAD BEEN FULLY SEATED INTO THEIR CORRESPONDING CONNECTORS AND SOLVENT APPLIED. THE TUBING MEASURED SLIGHTLY OVERSIZE AT THE DISCONNECTION AT THE MLL, WHICH WOULD HAVE RESULTED IN A TIGHTER FIT. THERE DID NOT APPEAR TO BE ANY MANUFACTURING ISSUES. THE TUBING ASSEMBLY IN QUESTION WAS MANUFACTURED ON AN AUTOMATIC TUBING ASSEMBLY MACHINE. THE PROD IS 100% VISUALLY INSPECTED BY THE OPERATOR FOR PROPER ASSEMBLY AND SUFFICIENT SOLVENT. AS A PRECAUTION IN JULY 2007, THE ASSEMBLY ROUTING INSTRUCTION FOR THE ASSEMBLY MACHINE WERE MODIFIED TO REQUIRE OPERATOR SIGN OFF FOR THE SOLVENT PURGING ON THE MACHINE ALONG WITH DOCUMENTING THE 100% INSPECTION. AS PART OF THE INSPECTION PROCESS ANY UNITS REMOVED DURING THE 100% WERE REWORKED BY THE OPERATOR. ALSO AS A PRECAUTION IN MID DEC 2007, THIS PRACTICE HAS BEEN DISCONTINUED. ANY UNITS REMOVED DURING THE 100% INSPECTION ARE BEING DISCARDED. SMITHS WAS ABLE TO CONFIRM THE ISSUE; HOWEVER, NO ROOT CAUSE COULD BE DETERMINED. NO ADD'L ACTION IS NECESSARY AT THIS TIME. SMITHS CONSIDERS THIS MDR CLOSED WITH THIS REPORT.

    Description of Event or Problem · 1

    SMITHS MEDICAL INTL REPORTED TO ANOTHER COUNTRY'S MFR THAT THE TUBINGS HAD DETACHED FROM THE LUER CONNECTORS. THE SYSTEMS WERE IN USE FOR NO LONGER THAN 4 DAYS. SOLUTIONS USED: SALINE AND RINGERS. THERE WAS NO PT INJURY OR TREATMENT REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DPS PRESSURE MONITORING KIT W/ ANTI SHUNT PRESSURE MONITORING SET DRS SMITHS MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK