BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DPS PRESSURE MONITORING KIT W/ ANTI SHUNT

    MDR report key: 1080108 · Received July 17, 2008

    Report

    Report Number
    1526863-2008-00023
    Event Type
    Malfunction
    Date Received
    July 17, 2008
    Date of Event
    April 11, 2008
    Report Date
    June 17, 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

    ADD'L LOT # 1284521. THE SUBASSEMBLY IN QUESTION IS A560 AND IS MFG BY SMITHS MEDICAL. THIS ASSEMBLY IS INCORPORATED INTO THE FINISHED PROD BY SMITHS MEDICAL. THE FINISHED PROD IS FURTHER ASSEMBLED, PACKAGED AND STERILIZED BY SMITHS MEDICAL. ONE A560 SUBASSEMBLY WAS REC'D WITH THE FEMALE LUER LOCK DISCONNECTED FROM THE TUBING. THE SOLVENT RING ON THE TUBING INDICATED THAT THE TUBING HAD BEEN FULLY SEATED INTO ITS CONNECTOR AND SOLVENT HAD BEEN APPLIED. THE TUBING MEASURED WITHIN SPEC. THERE DID NOT APPEAR TO BE ANY MFG ISSUES THAT WOULD HAVE CONTRIBUTED TO A SEPARATION. THE TUBING ASSEMBLY IN QUESTION WAS MFG ON AN AUTOMATIC TUBING ASSEMBLY MACHINE. THE PROD IS 100% VISUALLY INSPECTED BY THE OPERATOR FOR PROPER ASSEMBLY AND SUFFICIENT SOLVENT. AS PART OF THE INSPECTION PROCESS ANY UNITS REMOVED DURING THE 100% WERE REWORKED BY THE OPERATOR. AS A PRECAUTION IN 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

    FACILITY REPORTED TO SMITHS MEDICAL THAT THE LUER HAD DETACHED FROM THE TUBING. THE SAMPLE WAS IN USE FOR 8 HRS. 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 MONITOR SET DRS SMITHS MEDICAL NA 1284145

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK