Channel Drain 072221Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 00801741049835), received between Jul 18, 2017 and Feb 24, 2026 — classified as 1 injury, 52 malfunctions.

The most frequently reported specific device problem is “Disconnection” (17 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 25 most recent of 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AFTER BD REPRESENTATIVE HAD A CALL WITH CUSTOMER AND GOT SOME UNFORTUNATE NEWS. AFTER ORDERING MORE OF THE BD DRAINS, END USERS HAVE JUST FOUND MORE OF THIS CONTAMINATE. BD REPRESENTATIVE JUST WENT BACK TO THE SHELVES AND OPENED A NEW PACKAGE AND DID FIND THE WHITE PARTICLES AND HAIRS. PER FOLLOW INFORMATION RECEIVED ON 12FEB2026, BD SALES TEAM WAS ON SITE WITH COREWELL HEALTH TODAY TO DISCUSS THE ISSUE REPORTED ON, RELATED TO FOREIGN MATTER FOUND ON THE WOUND DRAINS. THEY PROVIDED THE SALES TEAM WITH THE IMPACTED LOT, WHICH IS NGKV4053, ASKED TO ENSURE THAT IS ADDED TO THE RECORD. PHOTOS WERE ALSO TAKEN. PER PHOTOS SENT BY BD REPRESENTATIVE, THE FIRST ONE WHERE THE WOUND DRAIN WAS OUT OF THE PACKET APPEARED TO HAVE A FUZZY ON THE OUTSIDE (THIS DOESN¿T REALLY SHOW UP IN THE PICTURE). THE CUSTOMER HAD THESE SELECTED WHERE IT APPEARED THERE WAS DEBRIS INSIDE THE WOUND DRAIN. THEY COULD NOT REALLY SEE THEM INSIDE THE TUBING, BUT THEY ARE GOING TO SEND TO COVINGTON IN THE RETURN BOX THAT HE WAS GIVEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24437461 ↗
• MalfunctionFeb 20, 2026Disconnection

  IT WAS REPORTED THAT THE CUSTOMER WAS EXPERIENCING ISSUES WITH THE 10FR WOUND DRAIN. THE DOCTOR HAS USED THIS DRAIN FOR MANY YEARS, AND SUDDENLY THE TUBING WAS SEPARATED WHEN THEY WERE TRYING TO PULL IT THROUGH THE PUNCTURE SITE. PER FOLLOW UP INFORMATION RECEIVED ON 06-FEB-2026, THEY HAVE PROVIDED TWO LOT NUMBERS. LOT# NGKQ0149 AND LOT# NGKU0126. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24405197 ↗
• MalfunctionJan 23, 2026Disconnection

  IT WAS REPORTED THAT THE CUSTOMER WAS EXPERIENCING ISSUES WITH THE 10FR WOUND DRAIN. THE DOCTOR HAS USED THIS DRAIN FOR MANY YEARS AND SUDDENLY THE TUBING WAS SEPARATED WHEN THEY WERE TRYING TO PULL IT THROUGH THE PUNCTURE SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24172892 ↗
• MalfunctionOct 24, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BEFORE USE, THERE WAS A FOREIGN OBJECT IN THE WOUND DRAIN PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23380641 ↗
• MalfunctionSep 18, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD 10FR ROUND DRAINS. WE OPENED 3 DIFFERENT PACKAGES OF STERILE DRAINS, AND ALL WERE UNUSABLE. THEY HAD FUZZY STICKY STUFF ON DRAINS, AND THE THIRD ONE HAD FUZZY SUBSTANCE AND A HAIR INSIDE THE STERILE PACKAGING. REFERENCE NUMBER 072221. ALL (3 PACKAGES) HAD SAME LOT NUMBER: NGKP0821. SURGEON HAS HAD SEVERAL ISSUES WITH 10F DRAINS FOR A WHILE ACROSS ALL OPERATING ROOMS LD, BL, BW. 1. WE ARE FINDING DEBRIS, POWDER- LIKE SUBSTANCE ON THEM. 2. VERY OFTEN THE DRAINS HAVE SMALL WHITE PIECES OF PLASTIC THAT ARE STUCK TO THE CLEAR PORTION OF THE DRAIN. IT IS SO FREQUENT THAT SURGEON HAS THE STAFF CHECK THE TUBING BEFORE WE INSERT THEM. ACCORDING TO SOME, THEY SEE THIS ACROSS DRAIN SIZES. NOT SURE IF SOMETHING IN THE MANUFACTURING CHANGED. 3. THERE HAVE BEEN TWO TIMES THAT THE DRAINS DID NOT FUNCTION AT THE END OF THE CASE. AFTER INVESTIGATING, THE SAME CLEAR JELL THAT IS AT THE END OF THE DRAIN BY THE TROCAR WAS FILLING THE FLUTED PART OF THE DRAIN AS WELL SO IT WAS NOT ABLE TO HOLD SUCTION. SURGEON IS HAVING STAFF FLUSH ALL THE DRAINS NOW BEFORE PLACEMENT AND CLOSE THE INCISION, SO WE KNOW THEY FUNCTION. EMI HAS FOUR DRAINS THAT SHE IS SENDING TO PRODUCT DEFECT T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23084139 ↗
• MalfunctionAug 18, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT PATIENT WAS THERE FOR SURGERY. SURGEON ALWAYS USED TWO 10FR ROUND DRAINS (LOT # NGKP0821). SURGEON OPENED TWO DRAINS AT BEGINNING OF CASE, BOTH DRAINS HAD FUZZY MATERIAL ON THE DRAIN IN THE STERILE PACKAGING. THIS HAS HAPPENED BEFORE. SURGEON SWITCHED AND HAD TO USE 15FR DRAINS WHICH SHOWED NO CONTAMINATION. NO PATIENT HARM WAS REPORTED. NO PHYSICAL SAMPLE WAS AVAILABLE. IT WAS REPORTED THAT PATIENT WAS THERE FOR SURGERY. SURGEON ALWAYS USED 10FR ROUND DRAINS WITH THIS SURGERY (LOT # NGKP0821). SURGEON OPENED 3 DIFFERENT PACKAGES OF STERILE DRAINS, AND ALL WERE UNUSABLE. THEY HAD FUZZY STICKY STUFF ON DRAINS, AND THE THIRD ONE HAD FUZZY SUBSTANCE AND A HAIR INSIDE THE STERILE PACKAGING. SURGEON PROCEEDED TO USE DIFFERENT SIZE DRAIN THAN NEEDED DUE TO THIS ONGOING PROBLEM. NO PATIENT HARM WAS REPORTED. PHYSICAL SAMPLES WERE AVAILABLE. IT WAS REPORTED THAT PHYSICIANS HAD SEVERAL ISSUES WITH 10F DRAINS FOR A WHILE (LOT # NGJW3604). WOUND DRAIN HAD DEBRIS, POWDER- LIKE SUBSTANCE ON THEM. VERY OFTEN THE DRAINS HAD SMALL WHITE PIECES OF PLASTIC THAT ARE STUCK TO THE CLEAR PORTION OF THE DRAIN. IT WAS SO FREQUENT THAT PHYSICIANS HAD THE STAFF CHECK THE TUBING BEFORE I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22827835 ↗
• MalfunctionAug 18, 2025Device Contamination with Body Fluid; Device Contamination with Body Fluid

  IT WAS REPORTED THAT PATIENT WAS THERE FOR A SURGERY. SURGEON ALWAYS USED TWO 10FR ROUND DRAINS (LOT# NGKP0821). SURGEON OPENED TWO DRAINS AT BEGINNING OF CASE, BOTH DRAINS HAD FUZZY MATERIAL ON THE DRAIN IN THE STERILE PACKAGING. THIS HAS HAPPENED BEFORE. SURGEON SWITCHED AND HAD TO USE 15FR DRAINS WHICH SHOWED NO CONTAMINATION. NO PATIENT HARM WAS REPORTED. NO PHYSICAL SAMPLE WAS AVAILABLE. IT WAS REPORTED THAT PATIENT WAS THERE FOR A SURGERY. SURGEON ALWAYS USED 10FR ROUND DRAINS WITH THIS SURGERY (LOT# NGKP0821). SURGEON OPENED 3 DIFFERENT PACKAGES OF STERILE DRAINS, AND ALL WERE UNUSABLE. THEY HAD FUZZY STICKY STUFF ON DRAINS, AND THE THIRD ONE HAD FUZZY SUBSTANCE AND A HAIR INSIDE THE STERILE PACKAGING. SURGEON PROCEEDED TO USE DIFFERENT SIZE DRAIN THAN NEEDED DUE TO THIS ONGOING PROBLEM. NO PATIENT HARM WAS REPORTED. PHYSICAL SAMPLE WAS AVAILABLE. IT WAS REPORTED THAT PHYSICIANS HAD SEVERAL ISSUES WITH 10F DRAINS FOR A WHILE (LOT# NGJW3604). WOUND DRAIN HAD DEBRIS, POWDER- LIKE SUBSTANCE ON THEM. VERY OFTEN THE DRAINS HAD SMALL WHITE PIECES OF PLASTIC THAT ARE STUCK TO THE CLEAR PORTION OF THE DRAIN. IT WAS SO FREQUENT THAT PHYSICIAN HAD THE STAFF CHECK THE TUBING BEFORE INS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22827815 ↗
• MalfunctionAug 18, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PATIENT WAS THERE FOR A SURGERY. SURGEON ALWAYS USED TWO 10FR ROUND DRAINS (LOT # NGKP0821). SURGEON OPENED TWO DRAINS AT BEGINNING OF CASE, BOTH DRAINS HAD FUZZY MATERIAL ON THE DRAIN IN THE STERILE PACKAGING. THIS HAS HAPPENED BEFORE. SURGEON SWITCHED AND HAD TO USE 15FR DRAINS WHICH SHOWED NO CONTAMINATION. NO PATIENT HARM WAS REPORTED. NO PHYSICAL SAMPLE WAS AVAILABLE. IT WAS REPORTED THAT PATIENT WAS THERE FOR A SURGERY. SURGEON ALWAYS USED 10FR ROUND DRAINS WITH THIS SURGERY (LOT # NGKP0821). SURGEON OPENED 3 DIFFERENT PACKAGES OF STERILE DRAINS AND ALL WERE UNUSABLE. THEY HAD FUZZY STICKY STUFF ON DRAINS AND THE THIRD ONE HAD FUZZY SUBSTANCE AND A HAIR INSIDE THE STERILE PACKAGING. SURGEON PROCEEDED TO USE DIFFERENT SIZE DRAIN THAN NEEDED DUE TO THIS ONGOING PROBLEM. NO PATIENT HARM WAS REPORTED. PHYSICAL SAMPLE WAS AVAILABLE. IT WAS REPORTED THAT PHYSICIANS HAD SEVERAL ISSUES WITH 10F DRAINS FOR A WHILE (LOT # NGJW3604). WOUND DRAIN HAD DEBRIS, POWDER- LIKE SUBSTANCE ON THEM. VERY OFTEN THE DRAINS HAD SMALL WHITE PIECES OF PLASTIC THAT ARE STUCK TO THE CLEAR PORTION OF THE DRAIN. IT WAS SO FREQUENT THAT PHYSICIAN HAD THE STAFF CHECK THE TUBING BEFORE IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22827814 ↗
• MalfunctionAug 18, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PATIENT WAS THERE FOR A SURGERY. SURGEON ALWAYS USED TWO 10FR ROUND DRAINS (LOT# NGKP0821). SURGEON OPENED TWO DRAINS AT BEGINNING OF CASE, BOTH DRAINS HAD FUZZY MATERIAL ON THE DRAIN IN THE STERILE PACKAGING. THIS HAS HAPPENED BEFORE. SURGEON SWITCHED AND HAD TO USE 15FR DRAINS WHICH SHOWED NO CONTAMINATION. NO PATIENT HARM WAS REPORTED. NO PHYSICAL SAMPLE WAS AVAILABLE. IT WAS REPORTED THAT PATIENT WAS THERE FOR A SURGERY. SURGEON ALWAYS USED 10FR ROUND DRAINS WITH THIS SURGERY (LOT# NGKP0821). SURGEON OPENED 3 DIFFERENT PACKAGES OF STERILE DRAINS, AND ALL WERE UNUSABLE. THEY HAD FUZZY STICKY STUFF ON DRAINS, AND THE THIRD ONE HAD FUZZY SUBSTANCE AND A HAIR INSIDE THE STERILE PACKAGING. SURGEON PROCEEDED TO USE DIFFERENT SIZE DRAIN THAN NEEDED DUE TO THIS ONGOING PROBLEM. NO PATIENT HARM WAS REPORTED. PHYSICAL SAMPLE WAS AVAILABLE. IT WAS REPORTED THAT PHYSICIANS HAD SEVERAL ISSUES WITH 10F DRAINS FOR A WHILE (LOT# NGJW3604). WOUND DRAIN HAD DEBRIS, POWDER- LIKE SUBSTANCE ON THEM. VERY OFTEN THE DRAINS HAD SMALL WHITE PIECES OF PLASTIC THAT ARE STUCK TO THE CLEAR PORTION OF THE DRAIN. IT WAS SO FREQUENT THAT PHYSICIAN HAD THE STAFF CHECK THE TUBING BEFORE INS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22827813 ↗
• MalfunctionJun 17, 2025Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT, DURING USE, THE NEEDLE WAS NOT SHARP ENOUGH TO PULL OUT THE CATHETER PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22235368 ↗
• MalfunctionApr 24, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE DOCTOR OPENED TWO DRAINS TO PLACE INTO A PATIENT. BOTH DRAIN TUBING WERE FOUND TO HAVE A SMALL PIECE OF WHITE PLASTIC ON THE TUBING. DOCTOR WAS ABLE TO REMOVE THE PLASTIC PARTS AND USE THE DRAINS, ALSO STATED THIS HAS BEEN AN ISSUE FOR MULTIPLE OTHER CASES SHE HAS BEEN IN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21900347 ↗
• MalfunctionSep 5, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE TUBE AND NEEDLE CAME OFF WHEN PULLED AFTER A PUNCTURE IN THE BARD SILICONE CHANNEL DRAIN. IT WAS A CONTINUOUS OCCURRENCE AND THERE WERE NO REPORTED PATIENT INJURY. PER SAMPLE RECEIVED ON 27MAR2024, IT WAS NOTED THAT AN ADDITIONAL CHANNEL DRAIN SAMPLE WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20144194 ↗
• MalfunctionAug 13, 2024Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT WOUND DRAIN TUBE WAS NOT ABLE TO DRAIN. SO ANOTHER ONE WAS OPENED AND DRAINED AS NORMAL. IT WAS REPORTED THAT THE FIVE BOTTLES WERE USED IN ONE CASE, THREE OF THE WOUND DRAIN WHICH DID NOT WORK FOR DRAINAGE. THEY REPORTED A PROBLEM WITH LOT#NGJN0817. THREE BOTTLES OF THE SAME LOT WERE USED IN THIS CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19974659 ↗
• MalfunctionAug 12, 2024Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT WOUND DRAIN TUBE WAS NOT ABLE TO DRAIN. SO, ANOTHER ONE WAS OPENED AND DRAINED AS NORMAL. IT WAS REPORTED THAT THE FIVE BOTTLES WERE USED IN ONE CASE, THREE OF THE WOUND DRAIN WHICH DID NOT WORK FOR DRAINAGE. THEY REPORTED A PROBLEM WITH LOT#NGJN0817. THREE BOTTLES OF THE SAME LOT WERE USED IN THIS CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19962685 ↗
• MalfunctionJun 4, 2024Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT DURING USE WOUND DRAIN NEEDLE WAS NOT SHARP ENOUGH WHEN PUNCTURING THE SKIN, IT DID NOT PENETRATE THE SKIN PROPERLY. IT WAS NOTED THAT THE GIVEN LOT# WAS NGHT2760.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19458202 ↗
• MalfunctionMay 21, 2024Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT DURING CHANNEL DRAIN PLACEMENT, THE NEEDLE WAS NO LONGER SHARP AND DOES NOT PENETRATE THE SKIN WELL, SO A SCALPEL INCISION WAS NECESSARY. THE CROSS-SECTION OF THE PENETRATION PART WAS DIRTY, SO THE TUBE FALLS OUT FROM THE NEEDLE WHEN THE TUBE WAS PULLED OUT.

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

  MAUDE report 19358141 ↗
• MalfunctionMay 16, 2024Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE NEEDLE OF WOUND DRAIN WAS NOT SHARP, AND THE INCISION WOUND WAS DIRTY, SO IT TOOK A LOT OF FORCE TO PULL IT OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19330257 ↗
• MalfunctionApr 25, 2024Disconnection; Material Fragmentation; Disconnection; Material Fragmentation

  IT WAS REPORTED THAT THE NEEDLE CAME OFF FROM THE WOUND DRAIN AFTER THE PUNCTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19180021 ↗
• MalfunctionApr 5, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING THE DRAIN PLACEMENT, THE TUBE CAME OFF THE TROCAR. ALSO, IT WAS NOTED THAT THE TROCAR WAS NOT CUT PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19051078 ↗
• MalfunctionMar 29, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT DRAIN PULLED OFF TROCAR WHEN PULLING IT THROUGH PATIENT. HAS HAPPENED 3 TIMES IN THE PAST 2 WEEKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19003568 ↗
• MalfunctionMar 29, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT DRAIN PULLED OFF TROCAR WHEN PULLING IT THROUGH PATIENT. HAS HAPPENED 3 TIMES IN THE PAST 2 WEEKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19003453 ↗
• MalfunctionMar 19, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT THE TUBE AND NEEDLE CAME OFF WHEN PULLED AFTER A PUNCTURE IN THE BARD SILICONE CHANNEL DRAIN. IT WAS A CONTINUOUS OCCURRENCE AND THERE WERE NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18929248 ↗
• MalfunctionDec 11, 2023Disconnection; Material Fragmentation; Disconnection; Material Fragmentation

  IT WAS REPORTED THAT THE CONNECTION BETWEEN THE NEEDLE AND THE TUBE WAS EASILY CAME OFF FROM WOUND DRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18301455 ↗
• MalfunctionJul 28, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS A FOREIGN MATERIAL FOUND ON THE BARD SILICONE CHANNEL DRAIN SOON AFTER USE ON THE PATIENT. PER FOLLOW-UP INFORMATION RECEIVED FROM IBC ON 20JUL2023, STATED THAT A REDDISH SPOT STAIN WAS OBSERVED THROUGHOUT WHITE PORTION OF TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17413079 ↗
• MalfunctionJul 6, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT UPON OPENING A PACKAGE, THE WOUND DRAIN GOT BROKEN BEFORE USING ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17276233 ↗