BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHANNEL DRAIN

    MDR report key: 21515657 · Received March 4, 2025

    Report

    Report Number
    1018233-2025-01429
    Event Type
    Malfunction
    Date Received
    March 4, 2025
    Date of Event
    February 11, 2025
    Report Date
    April 9, 2025
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    GBX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. 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.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE THIS INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS AND NO SAMPLE WAS AVAILABLE FOR EVALUATION. NO ADDITIONAL ACTIONS CAN BE TAKEN AT THIS TIME SINCE ROOT CAUSE WAS NOT IDENTIFIED. A DHR COULD NOT BE PERFORMED SINCE NO LOT NUMBER WAS PROVIDED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: ¿INDICATIONS: WOUND DRAINS ARE USED TO REMOVE EXUDATES FROM WOUND SITES. WARNINGS: AN EFFECTIVE CLOSED SUCTION DRAIN SYSTEM REQUIRES MAINTENANCE OF THE SYSTEM TO PRESERVE PATENCY. THE DRAIN MUST NOT BE ALLOWED TO OCCLUDE NOR THE RESERVOIR TO COMPLETELY FILL; AND RESERVOIR SUCTION MUST BE MAINTAINED IN ORDER FOR THE SYSTEM TO FUNCTION PROPERLY. VERIFY THAT THE SYSTEM IS FUNCTIONING PROPERLY. IF THE SYSTEM IS NOT MAINTAINED PROPERLY, SURGICAL COMPLICATIONS, INCLUDING HEMATOMAS, MAY RESULT. IN THE EVENT OF OCCLUSION OF THE DRAIN, ALL WOUND DRAINAGE VIA THE DRAIN CEASES. CAREFUL ATTENTION TO THE DRAIN WILL MINIMIZE THE POSSIBILITY OF THIS PROBLEM. IF OCCLUSION DOES OCCUR, THE DRAIN CAN BE ASPIRATED BY CONNECTING SUCTION TO THE RESERVOIR OUTLET OR TEMPORARILY DISCONNECTING THE DRAIN FROM THE RESERVOIR AND APPLYING SUCTION DIRECTLY TO THE DRAIN. IF AN AIR-TIGHT SEAL BETWEEN THE DRAIN AND THE SKIN WHERE THE DRAIN EMERGES IS NOT ACHIEVED, THE AIR LEAK MUST BE RECTIFIED OR THE SYSTEM MUST BE CONVERTED TO OPEN DRAINAGE. AN AIRTIGHT SEAL BETWEEN ALL SYSTEM COMPONENTS (DRAIN, ADAPTOR AND RESERVOIR) IS NECESSARY FOR PROPER SYSTEM FUNCTION. LEAVING THE SOFT SILICONE ELASTOMER DRAIN IMPLANTED FOR ANY PERIOD OF TIME SO AS TO CAUSE TISSUE INGROWTH AROUND THE DRAIN CAN INTERFERE WITH EASY REMOVAL AND MAY EFFECT THE PERFORMANCE OF THE DRAIN. THE SURGEON SHOULD MONITOR THE PATIENT¿S RATE OF WOUND HEALING. EVACUATORS SHOULD BE USED IN CARDIO-THORACIC SURGERY ONLY AFTER THE LUNG IS FULLY EXPANDED AND ALL AIR LEAKS HAVE SEALED. DRAIN PERFORATIONS OR CHANNELS MUST LIE WITHIN THE WOUND OR CAVITY TO BE DRAINED, OTHERWISE INADEQUATE DRAINAGE MAY RESULT. TO AVOID THE POSSIBILITY OF DRAIN DAMAGE OR BREAKAGE: 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. DRAINS 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. COMPLICATIONS: COMPLICATIONS WHICH MAY RESULT FROM THE USE OF THIS SUCTION DRAINAGE SYSTEM INCLUDE THE RISKS ASSOCIATED WITH METHODS UTILIZED IN THE SURGICAL PROCEDURE, AS WELL AS THE PATIENT'S DEGREE OF INTOLERANCE TO ANY FOREIGN OBJECT IN THE BODY. THE ADVANTAGES OF WOUND DRAINAGE, PARTICULARLY CLOSED SYSTEM DRAINAGE, ARE LOST IF AN AIR-TIGHT SEAL BETWEEN THE DRAIN AND THE SKIN WHERE THE DRAIN EMERGES IS NOT ACHIEVED, OR IF THE DRAIN IS ALLOWED TO BECOME OCCLUDED OR IF THE RESERVOIR IS NOT ACTIVATED PROPERLY, DOESN'T FUNCTION PROPERLY OR IS NOT MONITORED. EVACUATORS SHOULD BE EMPTIED AND REACTIVATED WHEN REQUIRED PER HOSPITAL PROTOCOL. IN THE EVENT AN AIR-TIGHT SEAL IS NOT ACHIEVED, THE RESERVOIR WILL RAPIDLY FILL WITH AIR FROM THE LEAK; SUBSEQUENT DRAINAGE TO THE RESERVOIR WILL OCCUR ONLY IF ALLOWED BY GRAVITY AND WOUND EXUDATE FORCING THE FLOW. ENTRY INTO THE RESERVOIR IS ALLOWED ONLY BY DISPLACEMENT OF AIR IN THE RESERVOIR BY WOUND EXUDATE FLOW. IN THIS DISPLACEMENT PROCESS, AIR REFLUX FROM THE RESERVOIR TO THE WOUND CAN OCCUR AND INCREASE THE LIKELIHOOD OF BACK-CONTAMINATION ACROSS THE ANTI-REFLUX VALVE. IN THE EVENT OF DRAIN OCCLUSION BY FIBRIN, CLOTS, OR OTHER PARTICULATE MATTER, ALL WOUND DRAINAGE VIA THE DRAIN CEASES. IF THE RESERVOIR IS NOT EMPTIED WHEN IT IS FULL, EQUILIBRIUM BETWEEN THE DRAIN AND RESERVOIR AT WOUND PRESSURE WILL ULTIMATELY OCCUR AND DRAINAGE FROM THE WOUND SITE WILL CEASE. WHEN THE RESERVOIR AND DRAIN ARE AT THE SAME PRESSURE AND THE RESERVOIR IS FULL OF FLUID, THE LIKELIHOOD OF BACK-CONTAMINATION ACROSS THE ANTI-REFLUX VALVE IS INCREASED. WHEN USED TO DRAIN THE PLEURAL CAVITY IN THE PRESENCE OF AN AIR LEAK, DRAINS MUST BE ATTACHED TO AN APPROPRIATE PLEURAL CAVITY DRAINAGE SYSTEM TO PREVENT TENSION PNEUMOTHORAX. CAUTION: FEDERAL (U.S.A.) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.¿ UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. 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 CUSTOMER EXPRESSED SOME CONCERN AROUND THE ABSENCE OF RIDGES WHERE THE STOPPER PLUGGED IN TO THE BULB. THEIR CURRENT PRODUCT HAD RIDGES THAT HELP THE STOPPER TO STAY IN PLACE. CUSTOMER HAD SOME ISSUES WITH A FEW OF THEIR DRAINS THAT THEY HAVE CONVERTED FROM CARDINAL TO BARD. PHYSICIANS WERE CONCERNED ABOUT THE BARD WOUND DRAIN NOT BEING TAPERED AND THEY WERE HAVING ISSUES WITH IT STAYING IN CORRECTLY. THE BARD ITEM NUMBERS THAT CUSTOMER EXPERIENCED ISSUES WITH WERE (PCN#072227, PCN#072229 AND PCN#072230). THE TOP ONE WAS THE 10F CUSTOMER HAVE CHANGED TO, THE BOTTOM ONE WAS A 15F OF THE KIND THEY USED TO STOCK IN 10F. THERE WAS A KNUCKLE OR BUMPER WHICH RESTRICTED THE DRAIN FROM MOVING BUT THE 10F DID NOT HAVE THAT BUMPER AND ACTUALLY GOT SMALLER, WHICH CLARIFIED WHY IT WOULD SLIDE OUT OF PLACE (PCN#072227).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CUSTOMER EXPRESSED SOME CONCERN AROUND THE ABSENCE OF RIDGES WHERE THE STOPPER PLUGGED IN TO THE BULB. THEIR CURRENT PRODUCT HAD RIDGES THAT HELP THE STOPPER TO STAY IN PLACE. CUSTOMER HAD SOME ISSUES WITH A FEW OF THEIR DRAINS THAT THEY HAVE CONVERTED FROM CARDINAL TO BARD. PHYSICIANS WERE CONCERNED ABOUT THE BARD WOUND DRAIN NOT BEING TAPERED AND THEY WERE HAVING ISSUES WITH IT STAYING IN CORRECTLY. THE BARD ITEM NUMBERS THAT CUSTOMER EXPERIENCED ISSUES WITH WERE (PCN#: 072227, PCN#: 072229 AND PCN#: 072230). THE TOP ONE WAS THE 10F CUSTOMER HAVE CHANGED TO, THE BOTTOM ONE WAS A 15F OF THE KIND THEY USED TO STOCK IN 10F. THERE WAS A KNUCKLE OR BUMPER WHICH RESTRICTED THE DRAIN FROM MOVING BUT THE 10F DID NOT HAVE THAT BUMPER AND ACTUALLY GOT SMALLER, WHICH CLARIFIED WHY IT WOULD SLIDE OUT OF PLACE (PCN#: 072227).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695771 CHANNEL DRAIN CHANNEL DRAIN GBX C.R. BARD, INC. (COVINGTON) -1018233 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other