BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIAVAC CLOSED WOUND SUCTION EVACUATOR, 100ML SILICONE EVACUATOR WITH ANTI-REFL

    MDR report key: 7259640 · Received February 9, 2018

    Report

    Report Number
    1018233-2018-00407
    Event Type
    Malfunction
    Date Received
    February 9, 2018
    Report Date
    March 1, 2018
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    GCY
    UDI-DI
    00801741049569
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. 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: ¿100CC SILICONE CLOSED WOUND SUCTION EVACUATOR AND SILICONE DRAINS INSTRUCTIONS FOR USE STERILE/SINGLE USE REORDER NUMBERS: 0070740 - 100CC SILICONE EVACUATOR 100CC SILICONE EVACUATOR KITS 100CC SILICONE EVACUATOR WITH: 0071360 - HUBLESS SILICONE FLAT DRAIN, 7MM WIDE, 3/4 PERFORATED, 20CM LONG 0071370 - HUBLESS SILICONE FLAT DRAIN, 10MM WIDE, 3/4 PERFORATED, 20CM LONG 0071430 - HUBLESS SILICONE FLAT DRAIN, 7MM WIDE, FULLY PERFORATED, 20CM LONG 0071440 - HUBLESS SILICONE FLAT DRAIN, 10MM WIDE, FULLY PERFORATED, 20CM LONG 100CC SILICONE CLOSED WOUND SUCTION EVACUATOR AND SILICONE DRAINS INDICATIONS FOR USE: THIS PRODUCT IS INTENDED FOR CLOSED WOUND DRAINAGE FOLLOWING HEAD AND NECK, ABDOMINAL, ENT, OB/GYN, PLASTIC SURGERY AND NEUROSURGERY. A. DRAIN PLACEMENT 1. PLACE WOUND DRAIN(S) WITHIN CRITICAL FLUID COLLECTION AREAS. 2. DRAW NON-PERFORATED SECTION OF WOUND DRAIN THROUGH SKIN UNTIL FLAT PORTION OF DRAIN IS SEATED APPROPRIATELY OR DRAIN INDICATOR MARK APPEARS AT THE SKIN SURFACE. 3. ATTACH NON-PERFORATED SECTION OF DRAIN EITHER TO DAVOL "Y"-CONNECTOR OR DIRECTLY TO EVACUATOR INLET PORT. NOTE: (1) SINCE THE 1/8" SILICONE ROUND DRAIN CANNOT CONNECT DIRECTLY TO THE EVACUATOR INLET PORT, DAVOL #0070780 "Y"-CONNECTOR MUST BE USED TO CONNECT TO EVACUATOR. (2) WHEN USING TWO DRAINS, THE DAVOL #0070790 "Y"-CONNECTOR MUST ALSO BE USED WITH 3/16", 1/4" SILICONE ROUND DRAINS AND 7, 10 AND 12.7MM SILICONE FLAT DRAINS. 4. WITH TWO SILICONE DRAINS; CUT OFF PLUG FROM CLOSED ARM OF "Y"- CONNECTOR. ATTACH BOTH DRAINS TO "Y"-CONNECTOR AND THEN ATTACH "Y"-CONNECTOR TO INLET PORT. CAUTION: DO NOT PUNCTURE OR PERFORATE DRAIN. B. TO ESTABLISH SUCTION IN EVACUATOR 1. OPEN CAPPED PORT. 2. SQUEEZE EVACUATOR. 3. CLOSE EMPTY PORT. ORIENT PLUG STRAP SO THAT PLUG TAB DOES NOT CONTACT INLET PORT. C. TO EMPTY CONTAINER 1. OPEN CAPPED PORT OVER COLLECTION BASIN. 2. SQUEEZE EVACUATOR TO EMPTY. D. TO RE-ESTABLISH SUCTION 1. REPEAT STEP "B" ABOVE. NOTE: REFLUX OF FLUID TO THE PATIENT IS MINIMIZED DURING REACTIVATION BY A BUILT-IN ANTI-REFLUX VALVE ON INLET PORT. E. TO READ FLUID VOLUME 1. OPEN CAPPED PORT TO RELEASE VACUUM. 2. READ AND RECORD APPROXIMATE VOLUME. 3. EMPTY AND REACTIVATE EVACUATOR. IMPORTANT: A. CHECK FOR FLUID ENTERING CLOSED WOUND SUCTION EVACUATOR. LACK OF FLOW MAY INDICATE ALL EXUDATE HAS BEEN REMOVED. CHECK ALL CONNECTIONS FOR AIR LEAKS AND WOUND TUBE PERFORATIONS FOR EXPOSURE ABOVE SKIN. B. SEVERAL ACTIVATIONS OF THE CLOSED WOUND SUCTION EVACUATOR MAY BE REQUIRED TO ESTABLISH SUCTION BECAUSE OF: - AIR ENTERING PARTIALLY CLOSED WOUND. - AN OPERATIVE AIR POCKET. C. THE ATTACHED STRAP MAY BE USED TO SECURE THE EVACUATOR TO THE PATIENT. PRECAUTIONS: 1. AVOID SUTURING THROUGH THE DRAINS TO MINIMIZE THE POSSIBILITY OF BREAKAGE. 2. DRAINS SHOULD LIE FLAT AND IN LINE WITH THE SKIN EXIT PATH. 3. PARTICULAR CARE SHOULD BE TAKEN TO AVOID ANY OBSTACLES TO THE DRAIN EXIT PATH. 4. DRAINS SHOULD BE CHECKED FOR FREE MOTION DURING CLOSURE TO MINIMIZE THE POSSIBILITY OF BREAKAGE DURING/AFTER REMOVAL. 5. DRAIN REMOVAL SHOULD BE DONE GENTLY BY HAND. DRAINS SHOULD NOT BE HANDLED WITH POINTED, TOOTHED OR BLUNT INSTRUMENTS WHICH COULD CAUSE CUTS OR NICKS AND LEAD TO SUBSEQUENT STRUCTURAL FAILURE OF THE DRAIN. WARNING: DRAIN BREAKAGE MAY REQUIRE SURGICAL REMOVAL. CAUTION: FEDERAL LAW (U.S.A.) RESTRICTS SALE OF THIS DEVICE TO OR ON THE ORDER OF A PHYSICIAN. WARNING: AN ISSUED OR REVISION DATE FOR THESE INSTRUCTIONS IS INCLUDED FOR THE USER'S INFORMATION. IN THE EVENT TWO YEARS HAVE ELAPSED BETWEEN THIS DATE AND PRODUCT USE, THE USER SHOULD CONTACT DAVOL INC. TO SEE IF ADDITIONAL PRODUCT INFORMATION IS AVAILABLE. REVISED DATE: DECEMBER, 2002 BARD AND ARE REGISTERED TRADEMARKS OF C. R. BARD, INC. OR AN AFFILIATE. C. R. BARD, INC. COVINGTON, GA 30014 1-800-526-4455 WWW.BARDMEDICAL.COM MANUFACTURED IN MEXICO PI7600150 12/02 ©2002 C. R. BARD, INC. ALL RIGHTS RESERVED." (B)(4) THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE LEAKED DURING USE. THERE WAS NO DELAY IN THE PROCEDURE OR IMPACT TO THE PATIENT.

    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. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE LEAKED DURING USE. THERE WAS NO DELAY IN THE PROCEDURE OR IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101892 RELIAVAC CLOSED WOUND SUCTION EVACUATOR, 100ML SILICONE EVACUATOR WITH ANTI-REFL WOUND EVACUATOR GCY C.R. BARD, INC. (COVINGTON) -1018233 NGBX0355 00801741049569

    Patients

    Seq Age Sex Outcome Treatment
    1