BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® DIGNISHIELD® STOOL MANAGEMENT SYSTEM

    MDR report key: 17914509 · Received October 11, 2023

    Report

    Report Number
    1018233-2023-07372
    Event Type
    Malfunction
    Date Received
    October 11, 2023
    Date of Event
    September 21, 2023
    Report Date
    September 26, 2023
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KNT
    PMA / PMN Number
    K133251
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE NO SAMPLE WAS RETURNED. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE DUE TO "LEAK AT THE JUMPER IN THE TS ZONE / PUNCTURED LUMEN". THE DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED WITHOUT A LOT NUMBER. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: ¿SMS002 BARD. INSTRUCTIONS FOR USE WARNING/AVERTISSEMEN/ADVERTENCIA. THERE IS A POTENTIAL RISK OF MISCONNECTIONS WITH CONNECTORS FROM OTHER HEALTHCARE APPLICATIONS, SUCH AS INTRAVENOUS EQUIPMENT, BREATHING AND DRIVING GAS SYSTEMS, URETHRAL/URINARY, LIMB CUFF INFLATION, NEURAXIAL DEVICES AND OTHER ENTERAL AND GASTRIC APPLICATIONS.A PISTON VALVE CONNECTOR LOCATED ON THE END OF THE DRAINAGE TUBE OF THE CATHETER ATTACHES TO THE COLLECTION BAG HUB SOCKET. WHEN THE COLLECTION BAG IS DISENGAGED FROM THE CATHETER, THE CATHETER AND BAG AUTOMATICALLY CLOSE TO PREVENT SPILLAGE. A BAG CAP IS PROVIDED TO SECURE THE CONTENTS OF THE COLLECTION BAG WHEN THE CATHETER IS REMOVED. THE 50 ML SYRINGE AND LUBRICATING JELLY SYRINGE ARE USED IN THE PREPARATION AND USE OF THE CATHETER. THE MEDI-AIRE® BIOLOGICAL ODOR ELIMINATOR MAY BE USED AS AN AIR FRESHENER IN THE ROOM. DO NOT SPRAY ON PATIENT OR DEVICE. THE TUBE CLAMP IS USED TO RETAIN MEDICATION DURING ADMINISTRATION OF MEDICATION. DIRECTIONS FOR USE: PUMP SPRAYER ONCE OR TWICE. DIRECT SPRAY AWAY FROM PATIENT. CONTAINS: WATER, SD ALCOHOL 40, TRIETHYLENE GLYCOL, BENZETHONIUM CHLORIDE, D&C COLOR, TETRASODIUM EDTA. CAUTION: MAY BE HARMFUL IF SWALLOWED. AVOID EYE CONTACT. KEEP OUT OF REACH OF CHILDREN. GENERAL GUIDELINES: THE DEVICE MAY BE REPLACED AS NEEDED, TO PERFORM PATIENT ASSESSMENT. FOR MEDICAL OR TECHNICAL QUESTIONS, PLEASE CONTACT MEDICAL SERVICES AND SUPPORT (B)(6). IF FURTHER INFORMATION OR GUIDELINES ARE NEEDED, PLEASE CONTACT BARD MEDICAL, AT THE ADDRESS BELOW: (B)(6), MEDI-AIRE AND PERMALENE ARE TRADEMARKS AND/OR REGISTERED TRADEMARKS OF C. R. BARD, INC. ©2020 C. R. BARD, INC. ALL RIGHTS RESERVED. 11. SYSTEM CARE, MAINTENANCE, AND MONITORING OF DEVICE A. TAKE NOTE OF THE BLACK POSITION INDICATOR LINE THAT IS PRINTED IN THE PROXIMAL SEGMENT OF THE TSZ. OBSERVE ITS RELATIVE POSITION TO THE PATIENT¿S ANUS. OBSERVE CHANGES IN THE LOCATION OF THE POSITION INDICATOR BAND AS A MEANS TO DETERMINE MOVEMENT OF THE RETENTION CUFF IN THE PATIENT¿S RECTUM. THIS MAY INDICATE THE NEED FOR THE CUFF OR DRAINAGE TUBE TO BE REPOSITIONED. B. CHANGE THE COLLECTION BAG AS NEEDED. C. SECURE THE BAG CAP ONTO EACH USED COLLECTION BAG AND DISCARD ACCORDING TO INSTITUTIONAL PROTOCOL FOR DISPOSAL OF MEDICAL WASTE. D. TO ENSURE UNOBSTRUCTED FLOW OF FECAL MATTER FROM THE DRAINAGE TUBE TO THE COLLECTION BAG, FREQUENTLY VERIFY THAT THE CATHETER AND COLLECTION BAG ARE POSITIONED SO THAT THE CATHETER IS NOT TWISTED, KINKED, OR EXTERNALLY COMPRESSED. E. FREQUENTLY VERIFY THAT WASTE IS NOT ACCUMULATING IN THE CATHETER DRAINAGE TUBE. F. VERIFY PATIENT IS NOT LYING ON DRAINAGE TUBE OR PORTS IN SUCH A MANNER AS TO POTENTIALLY CAUSE DISCOMFORT OR LOCALIZED PROLONGED PRESSURE. G. CHECK THE RETENTION CUFF VOLUME REGULARLY TO ENSURE PROPER INFLATION.¿ H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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 BD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A PROBLEM WITH THE PATIENT'S DIGNISHIELD. THE DEVICE WAS INSERTED ON (B)(6), AND THE WHITE IRRIGATION PORT GOT DISCONNECTED FROM THE GREEN PORT ON (B)(6). THE DEVICE WAS REPLACED ON (B)(6). AFTER REPLACING IT ON (B)(6) THE USER INSERTED A NEW DIGNISHIELD. WHEN THEY TRIED TO FLUSH THE INSIDE OF THE TUBE FROM THE PURPLE PORT ON (B)(6) THERE WAS NO WATER IN IT. SINCE THE CONDITION OF THE PATIENT'S BEDSORE WAS NOT GOOD, IT WOULD BE DIFFICULT TO REPLACE IT AGAIN, AND THE PLAN WAS TO USE IT UNTIL AROUND (B)(6), ONE MONTH AFTER INSERTION. PER FOLLOW-UP INFORMATION RECEIVED FROM IBC ON (B)(6) 2023, STATED THAT THE INFORMATION REGARDING WHETHER THE PATIENT'S BEDSORE WAS A PREEXISTING CONDITION OR NOT WAS NOT PROVIDED FROM CUSTOMER. THE USE OF THIS DEVICE WAS NOT ASSOCIATED WITH BEDSORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2237825 BARD® DIGNISHIELD® STOOL MANAGEMENT SYSTEM STOOL MANAGEMENT SYSTEM KNT C.R. BARD, INC. (COVINGTON) -1018233 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other