BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUBLESS SILICONE FLAT DRAIN

    MDR report key: 7453091 · Received April 23, 2018

    Report

    Report Number
    1018233-2018-01339
    Event Type
    Malfunction
    Date Received
    April 23, 2018
    Report Date
    June 4, 2018
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    GBX
    UDI-DI
    00801741090752
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE (THE INNER PACKAGE OF THE FLAT SILICONE DRAIN IS NOT SEALED ON ITS OWN AND IS INSTEAD SEALED TO THE SEAMS IN THE OUTER PACKET) WAS CONFIRMED. VISUAL EVALUATION NOTED THAT THE SAMPLE PACKAGE WAS OPENED. THE POUCH PRESENTED EVIDENCE THAT IT WAS SEALED. THE SEALING AREA DID NOT SHOW EVIDENCE OF DAMAGE, DISCONTINUED SEALING, OR COMPONENT CAUGHT IN THE SEAL. THE INNER BAG WAS ATTACHED ON THE POUCH FILM WITH THE ADHESIVE TAPE. THE ADHESIVE TAPE WAS REQUIRED TO CLOSE THE INNER BAG. 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: ¿A. USE WITH SINGLE FLAT DRAIN - 1. PLACE PERFORATED WOUND DRAIN WITHIN CRITICAL FLUID COLLECTION AREA OF WOUND. 2. DRAW DRAIN TUBE THROUGH SKIN/STAB WOUND INCISION UNTIL FLAT PORTION OF DRAIN IS SEATED APPROPRIATELY. 3. TRIM DRAIN TUBE TO DESIRED LENGTH AND ATTACH TO BLUE ADAPTER. CONNECT OTHER END OF BLUE ADAPTER TO Y-CONNECTOR. 4. INSERT CONNECTING TUBE IN RELIAVAC® PORT A, UP TO INDICATOR RING. B. USE WITH TWO FLAT DRAINS - 1. PLACE PERFORATED PORTION OF WOUND DRAINS WITHIN CRITICAL FLUID COLLECTION AREAS OF WOUND. 2. DRAW DRAIN TUBES THROUGH SKIN/STAB WOUND INCISION UNTIL FLAT PORTION OF THE DRAINS ARE SEATED APPROPRIATELY. 3. TRIM DRAIN TUBES TO DESIRED LENGTH. 4. CUT OFF PLUG FROM CLOSED ARM OF Y-CONNECTOR AND ATTACH BLUE ADAPTERS. 5. ATTACH DRAINS TO BLUE ADAPTERS. 6. INSERT CONNECTING TUBE IN RELIAVAC® PORT A, UP TO INDICATOR RING. CAUTION: PUNCTURES OR ADDITIONAL PERFORATIONS SHOULD NOT BE MADE IN THE SILICONE WOUND DRAIN. C. ATTACHING TO AUXILIARY SUCTION - 1. INSERT SUCTION ADAPTER INTO PORT B. 2. DURING AUXILIARY SUCTION, BALLOON WILL INFLATE AND EXUDATE WILL FLOW OVER BALLOON SURFACE FROM PORT A TO PORT B. 3. TO DISCONTINUE AUXILIARY SUCTION, REMOVE SUCTION ADAPTER AND CLOSE PORT B. CAUTION: DO NOT USE WITH WALL SUCTION IN EXCESS OF 210MM HG. D. TO ESTABLISH SUCTION - 1. OPEN PORT B. 2. PUMP BULB UNTIL BALLOON FILLS CONTAINER. 3. CLOSE PORT B. NOTE: HISSING SOUND IS NORMAL AND STOPS WHEN MAXIMUM SUCTION PRESSURE IS REACHED. POSSIBLE REFLUX OF FLUID TO THE PATIENT IS REDUCED DURING RELIAVAC® EVACUATOR REACTIVATION BY A BUILT-IN ANTI-REFLUX VALVE IN PORT A. E. TO EMPTY CONTAINER - 1. OPEN PORT B. 2. INVERT UNIT. 3. PUMP BULB TO EMPTY QUICKLY. F. TO RE-ESTABLISH SUCTION - 1. REPEAT STEP "D" ABOVE. G. TO READ FLUID VOLUME - 1. OPEN PORT B. 2. ALLOW BALLOON TO DEFLATE. 3. READ AND RECORD VOLUME. 4. TO REACTIVATE, REPEAT STEP "D" ABOVE. IMPORTANT A. CHECK FOR FLUID ENTERING RELIAVAC® EVACUATOR. LACK OF FLOW MAY INDICATE: - ALL EXUDATE HAS BEEN REMOVED. - WOUND DRAIN IS CLOGGED AND MAY REQUIRE IRRIGATION AND ASPIRATION (CONSULT PHYSICIAN). - AUXILIARY WALL SUCTION PRESSURE IS ABOVE 210MM HG. - DEFLATED BALLOON: CHECK ALL CONNECTIONS FOR AIR LEAK AND WOUND TUBE PERFORATIONS FOR EXPOSURE ABOVE THE SKIN. IF STILL DEFLATED, REPLACE EVACUATOR. B. WHEN NOT USING AUXILIARY SUCTION DURING SURGICAL WOUND CLOSURE, SEVERAL ACTIVATIONS OF THE RELIAVAC® EVACUATOR MAY BE REQUIRED TO ESTABLISH SUCTION BECAUSE OF: - AIR ENTERING PARTIALLY CLOSED WOUND. - AN OPERATIVE AIR POCKET. C. INSERT SAFETY PIN INTO HOLE IN COLLAR TO ATTACH EVACUATOR TO PATIENT'S CLOTHING OR BED LINEN. CAUTION: FEDERAL (U.S.A.) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. TO AVOID THE POSSIBILITY OF A HEMATOMA DUE TO WOUND EVACUATION, THE INSTRUCTIONS FOR USE SHOULD BE CAREFULLY FOLLOWED. 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 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. WARNING: SURGICAL REMOVAL MAY BE NECESSARY IF DRAIN IS DIFFICULT TO REMOVE OR BREAKS."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INNER PACKAGE OF THE FLAT SILICONE DRAIN WAS NOT SEALED ON ITS OWN AND WAS INSTEAD SEALED TO THE SEAMS OF THE OUTER PACKET.

    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 INNER PACKAGE OF THE FLAT SILICONE DRAIN WAS NOT SEALED ON ITS OWN AND WAS INSTEAD SEALED TO THE SEAMS OF THE OUTER PACKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292600 HUBLESS SILICONE FLAT DRAIN FLAT SILICONE DRAIN GBX C.R. BARD, INC. (COVINGTON) -1018233 NGCN3619 00801741090752

    Patients

    Seq Age Sex Outcome Treatment
    1