BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIAVAC CLOSED WOUND SUCTION SYSTEM

    MDR report key: 6429855 · Received March 23, 2017

    Report

    Report Number
    1018233-2017-01310
    Event Type
    Malfunction
    Date Received
    March 23, 2017
    Date of Event
    February 27, 2017
    Report Date
    May 17, 2017
    Manufacturer
    PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590
    Product Code
    GBX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RECEIVED 1 OPENED WOUND DRAIN ONLY. PER THE VISUAL INSPECTION, IT WAS NOTED THAT THE WHITE PART HAD A FLASH. THE REPORTED EVENT WAS CONFIRMED AS MANUFACTURING RELATED. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: "¿ DRAINS SHOULD BE CHECKED DURING CLOSURE FOR FREE MOTION TO AVOID POSSIBILITY OF BREAKAGE. DRAIN REMOVAL SHOULD BE DONE GENTLY BY HAND. THEY SHOULD NOT BE HANDLED WITH POINTED, TOOTHED OR SHARP INSTRUMENTS WHICH COULD CAUSE CUTS OR NICKS AND LEAD TO SUBSEQUENT STRUCTURAL FAILURE OF THE DRAIN. SURGICAL REMOVAL MAY BE NECESSARY IF DRAIN IS DIFFICULT TO REMOVE OR BREAKS." (B)(4) THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE DRAIN TUBE WAS DAMAGED PRIOR TO USE. AFTER OPENING THE PACKAGE, THE USER FOUND THAT THE END OF THE WHITE DRAIN TUBE (THE SIDE OF PATIENT) WAS JAGGED. THE DELAY OF PROCEDURE WAS LIMITED AND NO PATIENT INJURY, SUCH AS INFECTION, WAS REPORTED. IN MEDICON'S OBSERVATION, IT WAS CONFIRMED THAT THERE WAS LEDGE TO THE END OF THE WHITE DRAIN TUBE. THEREFORE, IT SEEMS THAT THIS DEVICE WAS DEFORMED AND NOT BROKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE DRAIN TUBE WAS DAMAGED PRIOR TO USE. AFTER OPENING THE PACKAGE, THE USER FOUND THAT THE END OF THE WHITE DRAIN TUBE (THE SIDE OF PATIENT) WAS JAGGED. THE DELAY OF PROCEDURE WAS LIMITED AND NO PATIENT INJURY, SUCH AS INFECTION, WAS REPORTED. IN (B)(4) OBSERVATION, IT WAS CONFIRMED THAT THERE WAS LEDGE TO THE END OF THE WHITE DRAIN TUBE. THEREFORE, IT SEEMS THAT THIS DEVICE WAS DEFORMED AND NOT BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209581 RELIAVAC CLOSED WOUND SUCTION SYSTEM RELIA VAC GBX PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 NGAU2182

    Patients

    Seq Age Sex Outcome Treatment
    1