Channel Drain 072231Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00801741049910), received between Jul 14, 2017 and Aug 15, 2025 — classified as 3 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (6 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 15, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE CUSTOMER FOUND A HAIR INSIDE A STERILE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22815342 ↗
• MalfunctionJun 27, 2025Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE TROCARS DID NOT CUT THROUGH THE PATIENT TISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22346408 ↗
• InjuryMar 6, 2025Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE TROCARS ARE NOT SHARP AND IT WAS NEARLY IMPOSSIBLE FOR THE DOCTOR TO PUNCTURE THROUGH SKIN USING THE TROCARS. AN INSANE AMOUNT OF FORCE WAS REQUIRED TO USE IT AND IT CAUSES A MAJOR SAFETY CONCERN FOR THE PATIENT AS WELL AS STAFF MEMBERS. AS PER THE MAIL NOTIFICATION RECEIVED ON 05APR2025, TROCAR WAS INSERTED IN A INSIDE TO OUTSIDE MANNER UNDER THE BREAST. WHEN TRYING TO PUSH TROCAR AND PUNCTURE THROUGH SKIN, IT WAS NOT SUCCESSFUL. TWO HANDS, MULTIPLE TRIES, AND A LOT OF FORCE WAS REQUIRED FOR THE TROCAR TO SERVE ITS PURPOSE. A SECOND DRAIN WAS PLACED AND A DIFFERENT SURGEON TRIED THE SAME ATTEMPT. AFTER PUSHING AND SEEING THEY COULD POTENTIALLY HARM THE PATIENT OR THEMSELF, THEY HAD TO USE A KNIFE AND A HEMOSTAT TO CREATE HIS OWN TUNNEL FOR THE TROCAR TO PASS THROUGH.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21535411 ↗
• MalfunctionFeb 21, 2025Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE WOUND DRAIN TUBING KINKED EASILY (PCN#072189, PCN#072231), AND TROCAR WAS DIFFICULT TO INSERT. VERY HARD TO PULL THROUGH THE RUBBER COMPONENT OF THE DRAIN THROUGH THE SKIN, ONE HAD TO PULL SO HARD THAT IT AVULSES THE SKIN FROM THE UNDERLYING TISSUE (PCN#072189, PCN#072231). CUSTOMER TUNNEL THE DRAIN, AND THE TROCAR WAS SO DULL (PCN#072189, PCN#072231) THEY HAD TO EXERT SUCH A LARGE AMOUNT OF FORCE THAT IT BECOME DIFFICULT TO CONTROL, CONCERN THIS MIGHT CAUSE THE TROCAR TO IMPALE OTHER AREAS OF THE PATIENT BODY. TROCAR COULD NOT BE BENT AND CAUSED DISCOMFORT AND INSERTION CHALLENGE CREATED A DELAY IN THE OPERATING ROOM AND COULD EXTEND CASE TIME BY A FEW MINUTES. MADE APPROPRIATE INSERTION OF THE DRAIN IN DIFFICULT IN HARD-TO-REACH PLACES, THIS COULD BE DANGEROUS AS THE TROCAR NEEDED TO BE INSERTED DEEPER AND COULD CAUSE BLEEDING. UNABLE TO SET THE CORRECT ANGLE OF EXIT, ESPECIALLY IN BELOW-KNEE AMPUTATION (PCN#072189, PCN#072231) AND DANGEROUS OR PAINFUL TO PATIENTS AND DIFFICULT TO REMOVE. SEVERAL PATIENTS WERE IN TEARS BECAUSE THE HUBS CAUSED LASTING PAIN ON REMOVAL. DUE TO THE ADDITION OF THE WHITE FLANGE ON THE TUBING, THE BARD CHANNEL DRAINS WERE HARDE

  Patient problems: Discomfort

  MAUDE report 21433350 ↗
• MalfunctionFeb 21, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE WOUND DRAIN TUBING KINKED EASILY (PCN#(B)(6)), AND TROCAR WAS DIFFICULT TO INSERT. VERY HARD TO PULL THROUGH THE RUBBER COMPONENT OF THE DRAIN THROUGH THE SKIN, ONE HAD TO PULL SO HARD THAT IT AVULSES THE SKIN FROM THE UNDERLYING TISSUE (PCN#(B)(6)). CUSTOMER TUNNEL THE DRAIN, AND THE TROCAR WAS SO DULL (PCN#(B)(6)) THEY HAD TO EXERT SUCH A LARGE AMOUNT OF FORCE THAT IT BECOME DIFFICULT TO CONTROL, CONCERN THIS MIGHT CAUSE THE TROCAR TO IMPALE OTHER AREAS OF THE PATIENT BODY. TROCAR COULD NOT BE BENT AND CAUSED DISCOMFORT AND INSERTION CHALLENGE CREATED A DELAY IN THE OPERATING ROOM AND COULD EXTEND CASE TIME BY A FEW MINUTES. MADE APPROPRIATE INSERTION OF THE DRAIN IN DIFFICULT IN HARD-TO-REACH PLACES, THIS COULD BE DANGEROUS AS THE TROCAR NEEDED TO BE INSERTED DEEPER AND COULD CAUSE BLEEDING. UNABLE TO SET THE CORRECT ANGLE OF EXIT, ESPECIALLY IN BELOW-KNEE AMPUTATION (PCN#(B)(6)) AND DANGEROUS OR PAINFUL TO PATIENTS AND DIFFICULT TO REMOVE. SEVERAL PATIENTS WERE IN TEARS BECAUSE THE HUBS CAUSED LASTING PAIN ON REMOVAL. DUE TO THE ADDITION OF THE WHITE FLANGE ON THE TUBING, THE BARD CHANNEL DRAINS WERE HARDER TO REMOVE AND CAUSED MORE PAIN FOR THE PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21432573 ↗
• MalfunctionFeb 21, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE WOUND DRAIN TUBING KINKED EASILY (PCN#072189, PCN#072231), AND TROCAR WAS DIFFICULT TO INSERT. VERY HARD TO PULL THROUGH THE RUBBER COMPONENT OF THE DRAIN THROUGH THE SKIN, ONE HAD TO PULL SO HARD THAT IT AVULSES THE SKIN FROM THE UNDERLYING TISSUE (PCN#072189, PCN#072231). CUSTOMER TUNNEL THE DRAIN, AND THE TROCAR WAS SO DULL (PCN#072189, PCN#072231) THEY HAD TO EXERT SUCH A LARGE AMOUNT OF FORCE THAT IT BECOME DIFFICULT TO CONTROL, CONCERN THIS MIGHT CAUSE THE TROCAR TO IMPALE OTHER AREAS OF THE PATIENT BODY. TROCAR COULD NOT BE BENT AND CAUSED DISCOMFORT AND INSERTION CHALLENGE CREATED A DELAY IN THE OPERATING ROOM AND COULD EXTEND CASE TIME BY A FEW MINUTES. MADE APPROPRIATE INSERTION OF THE DRAIN IN DIFFICULT IN HARD-TO-REACH PLACES, THIS COULD BE DANGEROUS AS THE TROCAR NEEDED TO BE INSERTED DEEPER AND COULD CAUSE BLEEDING. UNABLE TO SET THE CORRECT ANGLE OF EXIT, ESPECIALLY IN BELOW-KNEE AMPUTATION (PCN#072189, PCN#072231) AND DANGEROUS OR PAINFUL TO PATIENTS AND DIFFICULT TO REMOVE. SEVERAL PATIENTS WERE IN TEARS BECAUSE THE HUBS CAUSED LASTING PAIN ON REMOVAL. DUE TO THE ADDITION OF THE WHITE FLANGE ON THE TUBING, THE BARD CHANNEL DRAINS WERE HARDE

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21432187 ↗
• MalfunctionFeb 21, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE WOUND DRAIN TUBING KINKED EASILY (PCN# 072189, PCN# 072231), AND TROCAR WAS DIFFICULT TO INSERT. VERY HARD TO PULL THROUGH THE RUBBER COMPONENT OF THE DRAIN THROUGH THE SKIN, ONE HAD TO PULL SO HARD THIT IT AVULSES THE SKIN FROM THE UNDERLYING TISSUE (PCN# 072189, PCN# 072231). CUSTOMER TUNNEL THE DRAIN, AND THE TROCAR WAS SO DULL (PCN# 072189, PCN# 072231) THEY HAD TO EXERT SUCH A LARGE AMOUNT OF FORCE THAT IT BECOME DIFFICULT TO CONTROL, CONCERN THIS MIGHT CAUSE THE TROCAR TO IMPALE OTHER AREAS OF THE PATIENT BODY. TROCAR COULD NOT BE BENT AND CAUSED DISCOMFORT AND INSERTION CHALLENGE CREATED A DELAY IN THE OPERATING ROOM AND COULD EXTEND CASE TIME BY A FEW MINUTES. MADE APPROPRIATE INSERTION OF THE DRAIN IN DIFFICULT IN HARD-TO-REACH PLACES, THIS COULD BE DANGEROUS AS THE TROCAR NEEDED TO BE INSERTED DEEPER AND COULD CAUSE BLEEDING. UNABLE TO SET THE CORRECT ANGLE OF EXIT, ESPECIALLY IN BELOW-KNEE AMPUTATION (PCN# 072189, PCN# 072231) AND DANGEROUS OR PAINFUL TO PATIENTS AND DIFFICULT TO REMOVE. SEVERAL PATIENTS WERE IN TEARS BECAUSE THE HUBS CAUSED LASTING PAIN ON REMOVAL. DUE TO THE ADDITION OF THE WHITE FLANGE ON THE TUBING, THE BARD CHANNEL DRAINS WE

  Patient problems: Pain

  MAUDE report 21432185 ↗
• MalfunctionOct 29, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT HAIR FOUND IN PACKAGE OF CHANNEL DRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20559715 ↗
• MalfunctionOct 25, 2024Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE DOCTOR WAS COMPLAINING ABOUT THE 19FR DRAINS. DESPITE THE PACKAGING STATING THAT THE DRAINS WERE ¿HUBLESS", THERE WAS A SIGNIFICANT BUMP ON THE DRAIN, MAKING IT NOT SMOOTH IN IT¿S ENTIRETY. THIS DISCREPANCY LEAD THE SURGEON TO BELIEVE THAT THE DRAINS WERE NOT TRULY HUBLESS. ADDITIONALLY, PATIENTS WERE ALSO COMPLAINING THAT UPON REMOVAL OF THE DRAIN POSTOPERATIVELY THAT IT WAS VERY PAINFUL. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 20536799 ↗
• MalfunctionFeb 8, 2024Suction Failure; Suction Failure

  IT WAS REPORTED THAT THE WOUND DRAIN WAS NOT HOLDING SUCTION (MATERIAL #0070740). THEY WERE ALSO HAVING THESE ISSUES WITH PRODUCT (MATERIAL # 072231).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18667148 ↗
• MalfunctionAug 10, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE CUSTOMER HAD STRUGGLES WITH GETTING THE TROCARS TO GLIDE THROUGH THE SKIN WHEN INSERTING THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17497922 ↗
• MalfunctionAug 8, 2023Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE WOUND DRAINS (TROCAR) WERE NOT SHARP ENOUGH (MATERIAL # 072229 -NGHN2929 AND MATERIAL # 072231- NGHQ2398).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17480724 ↗
• MalfunctionApr 28, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT WHEN THE PRODUCT WAS OPENED, IT DID NOT CONTAIN A CONNECTION ADAPTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16831849 ↗
• MalfunctionMar 7, 2021Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE COMPLAINANT STRUGGLED WITH THE BARD DRAINS AS THE TROCARS WERE DULL. (REF: 072229). PER FOLLOW UP INFORMATION RECEIVED ON 09FEB2021, ADDITIONAL LOT NUMBERS WERE RECEIVED (NGEU3611, NGEN3356). THE ADDITIONAL INFORMATION RECEIVED ON 16FEB2021, INDICATED THAT THE DOCTORS WERE STILL ABLE TO MAKE AN INCISION USING EXCESSIVE FORCE AND ON OCCASION WOULD USE A KNIFE BLADE AS A LAST RESORT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11426602 ↗
• InjuryFeb 4, 2021Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE COMPLAINANT STRUGGLED WITH THE BARD DRAINS AS THE TROCARS WERE DULL. PER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON (B)(6) 2021 THE ADDITIONAL LOT NUMBERS RECEIVED WERE NGEU3611 NGEN3356. PER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON (B)(6) 2021 IT WAS STATED THAT THE DOCTORS WERE STILL ABLE TO MAKE AN INCISION USING EXCESSIVE FORCE AND ON OCCASION THE DOCTOR WOULD USE A KNIFE BLADE AS A LAST TRY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Consequences Or Impact To Patient

  MAUDE report 11280623 ↗
• InjuryDec 22, 2020Material Fragmentation; Difficult to Remove; Material Fragmentation; Difficult to Remove

  IT WAS REPORTED THAT THE TWO DRAINS WERE PLACED ON (B)(6)2020 AND (B)(6)2020. ONE DRAIN WAS REMOVED EASILY WITHOUT RESISTANCE AND THE SECOND ONE HAD A RESISTANCE. THE SURGEON ATTEMPTED TO REMOVE BESIDE THE TUBING WAS BROKEN. THE PATIENT WENT TO THE OPERATING ROOM THE NEXT MORNING (B)(6)2020 TO HAVE THE DISTAL END OF THE DRAIN REMOVED. ALSO THE PATIENT EXPERIENCED THE PAIN. PER FOLLOW UP VIA EMAIL ON (B)(6)2020 IT WAS STATED THAT THE PATIENT WENT TO THE OPERATING ROOM TO HAVE IT REMOVED AND THE PATIENT WAS RETURNED TO SURGERY AND HAD TO STAY AN EXTRA DAY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Code Available; Pain

  MAUDE report 11057416 ↗
• MalfunctionJun 27, 2018Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATERIAL WAS FOUND IN THE CHANNEL DRAIN.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 7643267 ↗
• MalfunctionAug 22, 2017Leak/Splash

  IT WAS REPORTED THAT A LEAK ON THE DRAINAGE TUBE WAS FOUND DURING THE SECOND DAY OF USE. THE USER ATTACHED TAPE TO COVER THE LEAKING AREA AND KEPT USING THE DEVICE UNTIL THE SEVENTH DAY OF USE..

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6809531 ↗
• MalfunctionJul 14, 2017Occlusion Within Device; Device Inoperable

  IT WAS REPORTED THAT THE DRAIN WAS PLUGGED. AS A RESULT, THE DEVICE WAS UNABLE TO FUNCTION. HOWEVER, THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6713787 ↗