BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIAVAC CLOSED WOUND SUCTION EVACUATOR

    MDR report key: 8902864 · Received August 16, 2019

    Report

    Report Number
    1018233-2019-04828
    Event Type
    Injury
    Date Received
    August 16, 2019
    Date of Event
    July 3, 2019
    Report Date
    August 16, 2019
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    GCY
    UDI-DI
    00801741049460
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT IS INCONCLUSIVE SINCE NO DEVICE WAS RETURNED FOR EVALUATION. A POTENTIAL ROOT CAUSE IDENTIFIED FOR THIS FAILURE IS "USER NOT AWARE OF DEVICE LIMITATIONS: DRAIN WAS SUTURED THROUGH, DRAIN WAS RAPIDLY REMOVED FROM PATIENT, AND/OR - FREE MOTION WAS NOT CHECKED DURING DRAIN CLOSURE". THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "INDICATIONS: SILICONE ROUND DRAINS ARE INDICATED FOR USE WITH SELECTED BARD EVACUATORS FOR CLOSED WOUND DRAINAGE FOLLOWING HEAD AND NECK, ABDOMINAL, ENT, OB/GYN, PLASTIC AND NEUROSURGERY. WARNING: WHEN PLACING DRAIN(S) CARE SHOULD BE TAKEN TO ENSURE THAT THE PERFORATED PORTION OF THE WOUND DRAIN LIES COMPLETELY WITHIN THE CONFINES OF THE WOUND. READ PRODUCT INSERT PROVIDED WITH THE CLOSED WOUND EVACUATOR FOR DETAILED INSTRUCTIONS, WARNINGS AND PRECAUTIONS ASSOCIATED WITH THE USE OF THE EVACUATOR DEVICE. TO AVOID THE POSSIBILITY OF DRAIN DAMAGE OR BREAKAGE: ADDITIONAL PERFORATIONS SHOULD NOT BE MADE IN THE DRAINS. AVOID SUTURING THROUGH DRAINS. DRAINS SHOULD LIE FLAT AND IN LINE WITH THE SKIN EXIT AREAS. PARTICULAR CARE SHOULD BE TAKEN TO AVOID ANY OBSTACLES TO THE DRAIN EXIT PATH. DRAINS SHOULD BE CHECKED FOR FREE MOTION DURING CLOSURE TO MINIMIZE THE 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. SILICONE ROUND DRAIN: FOR USE WITH RELIAVAC® 100, RELIAVAC® 400, 100CC SILICONE EVACUATORS, AND 3-SPRING EVACUATORS: REF O.D. LENGTH, HOLE PATTERN, 0070210, 49" (124.4CM), 10" (25.4CM), 0070310, 49" (124.4CM), MEDIUM 1/8" (10 FR., 3.2 MM), WITH X-RAY OPAQUE STRIPE, 10" (25.4CM), MEDIUM 1/8" (10 FR., 3.2 MM), WITH X-RAY OPAQUE STRIPE, ATTACHED TROCAR. ATTENTION, READ DIRECTIONS PRIOR TO USE. INSTRUCTIONS FOR USE: DRAIN PLACEMENT: PLACE PERFORATED WOUND DRAIN WITHIN THE CRITICAL FLUID COLLECTION AREA OF WOUND. DRAW NON-PERFORATED SECTION OF WOUND DRAIN THROUGH TO THE OUTSIDE UNTIL DRAIN INDICATOR MARK APPEARS AT THE SKIN SURFACE. TWO SETS OF INDICATOR MARKS AID PLACEMENT OF THE DRAIN. REMOVE TROCAR ONLY BY CUTTING THE DRAIN ONE INCH FROM END OF TROCAR. TRIM NON-PERFORATED SECTION OF DRAIN TO DESIRED LENGTH. FOR BARD 100CC SILICONE AND RELIAVAC 100 EVACUATORS. SINGLE DRAIN PLACEMENT: REMOVE ADAPTER WITH CONNECTOR FROM POUCH. INSERT ADAPTER END INTO NON-PERFORATED SECTION OF DRAIN. INSERT CONNECTING TUBE OF DRAIN TO ADAPTER PORT OF EVACUATOR. FOR TWO DRAIN PLACEMENT: FOR BARD 100CC SILICONE EVACUATORS: ATTACH SECOND DRAIN TO ADAPTER. ATTACH CONNECTING TUBE OF BOTH SILICONE DRAINS TO BARD'S Y-CONNECTOR (#0070790) AND CONNECT Y-CONNECTOR TO EVACUATOR DRAIN PORT. FOR RELIAVAC 100 (USE BLUE ADAPTER IN DRAIN PACKAGE AND Y-CONNECTOR IN EVACUATOR PACKAGE): CUT OFF PLUG FROM CLOSED ARM OF Y-CONNECTOR. REMOVE BLUE ADAPTERS FROM POUCHES. INSERT INTO Y-CONNECTOR. ATTACH BOTH DRAINS TO BLUE ADAPTERS. FOR RELIAVAC 400 AND 3-SPRING EVACUATORS: SINGLE DRAIN PLACEMENT: ENSURE OPEN END OF Y-CONNECTOR IS OPEN OR CUT TO 1/4" MARK. REMOVE BLUE ADAPTER FROM POUCH. INSERT INTO Y-CONNECTOR. ATTACH DRAIN TO BLUE ADAPTER. FOR TWO DRAIN PLACEMENT: CUT OFF PLUG FROM CLOSED ARM OF Y-CONNECTOR. REMOVE BLUE ADAPTER FROM POUCH. INSERT INTO Y-CONNECTOR. ATTACH BOTH DRAINS TO BLUE ADAPTERS."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN REMOVING A SILICONE DRAIN, A PIECE OF THE DRAIN BROKE OFF IN THE PATIENTS KNEE. PER ADDITIONAL INFORMATION RECEIVED FROM THE COMPLAINANT ON 5-AUG-2019, DURING REMOVAL THE DRAIN WAS DIFFICULT TO REMOVE AND THE END APPEARED DAMAGED. THE PATIENT WAS SENT TO X-RAY WHERE A 1CM FRAGMENT WAS IDENTIFIED ADJACENT TO THE OUTER ASPECT OF THE MEDIAL TIBIAL PLATEAU. THE PHYSICIAN AND PATIENT MADE THE DECISION TO LEAVE THE PIECE IN THE PATIENT. REMOVAL OF THE 1CM FRAGMENT WAS NOT PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697006 RELIAVAC CLOSED WOUND SUCTION EVACUATOR WOUND DRAIN GCY C.R. BARD, INC. (COVINGTON) -1018233 NGCZ1325 00801741049460

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention