CHANNEL DRAIN
Report
- Report Number
- 1018233-2025-01244
- Event Type
- Malfunction
- Date Received
- February 25, 2025
- Date of Event
- February 6, 2025
- Report Date
- May 5, 2025
- Manufacturer
- C.R. BARD, INC. (COVINGTON) -1018233
- Product Code
- GBX
- UDI-DI
- 00801741119194
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE REPORTED EVENT WAS CONFIRMED MANUFACTURING RELATED. VISUAL EVALUATION OF THE RETURNED SAMPLE NOTED THREE UNOPENED AND ONE OPEN (WITH ORIGINAL PACKAGING), CHANNEL DRAINS WITH TROCAR. VISUAL INSPECTION OF THE SAMPLE NOTED THAT THE CHANNEL DRAIN WAS MEASURED, AND THE SIZE WAS 15 FR INSTEAD OF 19FR AND THE MATERIAL NUMBER V072231 AS STATED IN THE PACKAGE LABEL. THIS DOES NOT MEET SPECIFICATION AND THE LOT# NGJV0169 PROVIDED IS FOR COMPONENT ITEM NUMBER V072229. NO ACTIONS CAN BE TAKEN AT THIS TIME SINCE A ROOT CAUSE WAS NOT IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATES 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 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 AFFECT 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. 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, DOES NOT 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 3 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. CORRECTION- D, E, H. 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 FACILITY WANTED TO RETURN 227 PACKAGES OF WOUND DRAIN, WHICH CAME IN THE WRONG SIZE. THE LABEL READS 19 FR, BUT THEY WERE ACTUALLY 15 FR. THE CUSTOMER WAS TRYING TO FIGURE OUT WHAT TO DO WITH THIS DEFECTIVE PRODUCT. THIS WAS SENT OVER TO CLAIMS TO ISSUE AN RMA NUMBER FOR RETURN WHEN IT SHOULD HAVE GONE OVER TO THE PRODUCT COMPLAINTS TEAM IF THERE WAS A PACKAGING OR LABELING COMPLAINT. PER CUSTOMER VIA EMAIL ON 04MAR2025, IT WAS REPORTED THAT 227 PACKAGES LABELED 19F, BUT TUBING WAS ACTUALLY 15F. NO REPORTED PATIENT INJURY.
IT WAS REPORTED THAT THE FACILITY WANTED TO RETURN 227 PACKAGES OF WOUND DRAIN, WHICH CAME IN THE WRONG SIZE. THE LABEL READS 19 FR, BUT THEY WERE ACTUALLY 15 FR. THE CUSTOMER WAS TRYING TO FIGURE OUT WHAT TO DO WITH THIS DEFECTIVE PRODUCT. THIS WAS SENT OVER TO CLAIMS TO ISSUE AN RMA NUMBER FOR RETURN WHEN IT SHOULD HAVE GONE OVER TO THE PRODUCT COMPLAINTS TEAM IF THERE WAS A PACKAGING OR LABELING COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1088166 | CHANNEL DRAIN | CHANNEL DRAIN | GBX | C.R. BARD, INC. (COVINGTON) -1018233 | NGJV0169 | 00801741119194 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |