CHANNEL DRAIN
Report
- Report Number
- 1018233-2024-07910
- Event Type
- Malfunction
- Date Received
- December 11, 2024
- Date of Event
- November 19, 2024
- Report Date
- January 28, 2025
- Manufacturer
- C.R. BARD INC. (COVINGTON) -1018233
- Product Code
- GBX
- UDI-DI
- 00801741049897
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE REPORTED PRODUCT NUMBER IS UNKNOWN. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. 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.
THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE THIS INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS AND NO SAMPLE WAS AVAILABLE FOR EVALUATION. NO ACTIONS CAN BE TAKEN AT THIS TIME SINCE A 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 PATIENTS 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 PATIENTS 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, DOESNT FUNCTION PROPERLY OR IS NOT MONITORED. EVACUATORS SHOULD BE EMPTIED AND RE-ACTIVATED 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. DRAIN PLACEMENT: THE SURGEON SHOULD IRRIGATE THE WOUND WITH STERILE FLUID, THEN SUCTION THE IRRIGATING FLUID AND GROSS DEBRIS FROM THE OPERATIVE SITE. TUBES SHOULD LIE FLAT AND IN LINE WITH THE ANTICIPATED SKIN EXIT. TO FACILITATE LATER REMOVAL BY MANUAL TRACTION, THE TUBING SHOULD NOT BE CURLED, PINCHED, OR SUTURED INTERNALLY. POSITIONING OF THE DRAIN IN THE BODY CAVITY, AS WELL AS THE NUMBER OF DRAINS INDICATED, SHOULD BE DETERMINED BY THE OPERATING SURGEON. DRAIN TUBING SHOULD BE PLACED WITHIN THE WOUND BY APPROXIMATING THE AREAS OF CRITICAL FLUID COLLECTION. CARE MUST BE TAKEN TO ENSURE THAT ALL DRAIN PERFORATIONS OR CHANNELS LIE COMPLETELY WITHIN THE WOUND OR CAVITY TO BE DRAINED. TAPING OR A TRIPLE LOOP SUTURE (AROUND AND NOT THROUGH THE TUBING) WILL AID IN PREVENTING ACCIDENTAL DRAIN DISPLACEMENT. DEEP DRAINAGE IS BEST ACCOMPLISHED BY USING ONE OR MORE DRAINS FOR EACH LEVEL OF TISSUE. EACH LEVEL SHOULD BE EVACUATED BY A SEPARATE VACUUM SOURCE. CARE MUST BE EXERCISED TO AVOID DAMAGE TO THE DRAIN (SEE WARNINGS). THE TUBING SHOULD BE REPEATEDLY CHECKED DURING CLOSURE FOR FREE MOTION TO AVOID BREAKAGE AND/OR FRAGMENT RETENTION WITHIN THE WOUND. 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.
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.
IT WAS REPORTED THAT THE ADAPTER WHICH CAME INSIDE THE 15F ROUND BARD DRAIN (L#2221069) DID NOT FIT ON THE NEW BD BULB RESERVOIRS (L# 2014696). THE CUSTOMER STATED THAT THE ADAPTER WAS IMPORTANT TO OBTAINING A GOOD SEAL, AND IT WAS CRUCIAL THAT THE ADAPTER BE COMPATIBLE WITH THE BULB RESERVOIR. IT LOOKED LIKE THEY NEEDED TO GO BACK TO THE ETHICON BLAKE DRAIN THEY WERE USING BEFORE THE CONVERSION (L# 36306). THE 19F BARD DRAIN (L# 2221070) INCLUDES TWO ADAPTERS, ONE OF WHICH FITS THE RESERVOIR SO THAT THE DRAIN WOULD BE OKAY FOR ITS CONTINUED USE. PER FOLLOW UP VIA MAIL ON 19NOV2024,THE CUSTOMER STATED ESSENTIALLY, THE 15F ROUND BARD DRAIN (BD# 07229) DID NOT CREATE A TIGHT SEAL WITH THE BULB (BD#0070740) AS THE ADAPTER MIGHT NOT BE COMPATIBLE. THE REPRESENTATIVE ADVISED THE CUSTOMER THAT THIS CHANNEL DRAIN (072229) CONNECTED DIRECTLY TO THE EVACUATOR (0070740) AND DID NOT REQUIRE THE CONNECTOR THAT WAS IN THE DRAIN PACKAGING AND ALSO ATTACHED AN IMAGE OF HOW IT SHOULD BE CONNECTED. THE CONNECTOR WOULD BE USED IF THEY WERE GOING TO USE A 3-SPRING PVC EVACUATOR. THERE WAS A LINK TO THE WOUND DRAIN BROCHURE WHICH WOULD ALSO HELP THEM TO UNDERSTAND WHEN TO USE THE CONNECTOR.
IT WAS REPORTED THAT THE ADAPTER WHICH CAME INSIDE THE 15F ROUND BARD DRAIN (L #2221069) DID NOT FIT ON THE NEW BD BULB RESERVOIRS (L #2014696). THE CUSTOMER STATED THAT THE ADAPTER WAS IMPORTANT TO OBTAINING A GOOD SEAL, AND IT WAS CRUCIAL THAT THE ADAPTER BE COMPATIBLE WITH THE BULB RESERVOIR. IT LOOKED LIKE THEY NEEDED TO GO BACK TO THE ETHICON BLAKE DRAIN THEY WERE USING BEFORE THE CONVERSION (L# 36306). THE 19F BARD DRAIN (L #2221070) INCLUDES TWO ADAPTERS, ONE OF WHICH FITS THE RESERVOIR SO THAT THE DRAIN WOULD BE OKAY FOR ITS CONTINUED USE. PER FOLLOW UP VIA MAIL ON 19NOV2024,THE CUSTOMER STATED ESSENTIALLY, THE 15F ROUND BARD DRAIN (BD #07229) DID NOT CREATE A TIGHT SEAL WITH THE BULB (BD #0070740) AS THE ADAPTER MIGHT NOT BE COMPATIBLE. THE REPRESENTATIVE ADVISED THE CUSTOMER THAT THIS CHANNEL DRAIN (072229) CONNECTED DIRECTLY TO THE EVACUATOR (0070740) AND DID NOT REQUIRE THE CONNECTOR THAT WAS IN THE DRAIN PACKAGING AND ALSO ATTACHED AN IMAGE OF HOW IT SHOULD BE CONNECTED. THE CONNECTOR WOULD BE USED IF THEY WERE GOING TO USE A 3-SPRING PVC EVACUATOR. THERE WAS A LINK TO THE WOUND DRAIN BROCHURE WHICH WOULD ALSO HELP THEM TO UNDERSTAND WHEN TO USE THE CONNECTOR.
IT WAS REPORTED THAT THE ADAPTER WHICH CAME INSIDE THE 15F ROUND BARD DRAIN (L#: 2221069) DID NOT FIT ON THE NEW BD BULB RESERVOIRS (L#: 2014696). THE CUSTOMER STATED THAT THE ADAPTER WAS IMPORTANT TO OBTAINING A GOOD SEAL, AND IT WAS CRUCIAL THAT THE ADAPTER BE COMPATIBLE WITH THE BULB RESERVOIR. IT LOOKED LIKE THEY NEEDED TO GO BACK TO THE ETHICON BLAKE DRAIN THEY WERE USING BEFORE THE CONVERSION (L#: 36306). THE 19F BARD DRAIN (L#: 2221070) INCLUDES TWO ADAPTERS, ONE OF WHICH FITS THE RESERVOIR SO THAT THE DRAIN WOULD BE OKAY FOR ITS CONTINUED USE. PER FOLLOW UP VIA MAIL ON 19NOV2024, THE CUSTOMER STATED ESSENTIALLY, THE 15F ROUND BARD DRAIN (BD#: 07229) DID NOT CREATE A TIGHT SEAL WITH THE BULB (BD#: 0070740) AS THE ADAPTER MIGHT NOT BE COMPATIBLE. THE REPRESENTATIVE ADVISED THE CUSTOMER THAT THIS CHANNEL DRAIN (072229) CONNECTED DIRECTLY TO THE EVACUATOR (0070740) AND DID NOT REQUIRE THE CONNECTOR THAT WAS IN THE DRAIN PACKAGING AND ALSO ATTACHED AN IMAGE OF HOW IT SHOULD BE CONNECTED. THE CONNECTOR WOULD BE USED IF THEY WERE GOING TO USE A 3-SPRING PVC EVACUATOR. THERE WAS A LINK TO THE WOUND DRAIN BROCHURE WHICH WOULD ALSO HELP THEM TO UNDERSTAND WHEN TO USE THE CONNECTOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2574527 | CHANNEL DRAIN | CHANNEL DRAIN | GBX | C.R. BARD INC. (COVINGTON) -1018233 | UNK | 00801741049897 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |