Channel Drain 072228Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741049880), received between Jun 11, 2018 and Apr 17, 2026 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2026Complete Blockage

  IT WAS REPORTED THAT THE CUSTOMER HAD OCCURRED THE PREVIOUS WEEK WITH A 15FR ROUND DRAIN. DR HAD BEEN THE PROVIDER, AND IT HAD BEEN A BREAST CASE. THE CHARGE NURSE FROM GENERAL SURGERY HAD MENTIONED THAT THE DOCTOR DID NOT PREFER THE BARD DRAINS. A 15FR DRAIN HAD BEEN TRIED AND HAD CLOTTED, SO IT WAS CHANGED TO A 19FR DRAIN, WHICH HAD ALSO CLOTTED. THE CHARGE NURSE HAD STATED THAT A 24FR DRAIN WOULD NOT BE USED FOR A BREAST CASE. THE TEAM HAD RETURNED TO USING THE ETHICON DRAIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24918000 ↗
• MalfunctionJun 13, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT SEVERAL CONCERNS REGARDING THE CURRENT DRAIN SETUP. PATIENTS WERE EXPERIENCING SIGNIFICANT DISCOMFORT DURING REMOVAL, WHICH HAD BEEN DESCRIBED AS PAINFUL. ADDITIONALLY, THE FLANGES TEND TO STRETCH THE DRAIN WHEN MANIPULATED, INCREASING THE RISK OF THE DRAIN DETACHING UNINTENTIONALLY. THESE ISSUES NOT ONLY IMPACT PATIENT COMFORT BUT ALSO RAISE POTENTIAL SAFETY CONCERNS THAT NEED TO BE ADDRESSED PROMPTLY. NO MEDICAL INTERVENTION WAS REPORTED. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 28MAY2025, THE FLANGE ON THE DRAIN CURLS UP ON ITSELF WHEN IT WAS STRETCHED. THEN THEY TUGGED ON IT TO DEMONSTRATE, IT BROKE INTO 2 PIECES. THE OTHER 15 ROUND CHANNEL BLAKE HUB LESS DRAIN BROUGHT FROM GMH TO PMH FOR THEM TO TRY WAS TOO FLIMSY, KINKS ON ITSELF SO IT DID NOT DRAIN, AND DID NOT HAD A LONG ENOUGH OR FIRM ENOUGH AREA TO SECURE IT WITH SUTURE. THEY USED THEM YESTERDAY HAD A VERY DIFFICULT TIME TYING THE SECURING STITCH TIGHT ENOUGH TO HOLD IT WITHOUT CRIMPING THE DRAIN AND PREVENTING DRAIN FUNCTION. THE AREA WHERE IT WAS SUPPOSED TO BE SECURED WAS PROXIMAL TO THE BLACK DOT AND YET WAS SO SHORT THAT MINOR MOVEMENTS IN THE DRAIN WOULD CAUSE THE CHANNELS TO BE IN THE D

  Patient problems: Discomfort; Pain

  MAUDE report 22203661 ↗
• MalfunctionJun 13, 2025Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT SEVERAL CONCERNS REGARDING THE CURRENT DRAIN SETUP. PATIENTS WERE EXPERIENCING SIGNIFICANT DISCOMFORT DURING REMOVAL, WHICH HAD BEEN DESCRIBED AS PAINFUL. ADDITIONALLY, THE FLANGES TEND TO STRETCH THE DRAIN WHEN MANIPULATED, INCREASING THE RISK OF THE DRAIN DETACHING UNINTENTIONALLY. THESE ISSUES NOT ONLY IMPACT PATIENT COMFORT BUT ALSO RAISE POTENTIAL SAFETY CONCERNS THAT NEED TO BE ADDRESSED PROMPTLY. NO MEDICAL INTERVENTION WAS REPORTED. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 28MAY2025, THE FLANGE ON THE DRAIN CURLS UP ON ITSELF WHEN IT WAS STRETCHED. THEN THEY TUGGED ON IT TO DEMONSTRATE, IT BROKE INTO 2 PIECES. THE OTHER 15 ROUND CHANNEL BLAKE HUB LESS DRAIN BROUGHT FROM GMH TO PMH FOR THEM TO TRY WAS TOO FLIMSY, KINKS ON ITSELF SO IT DID NOT DRAIN, AND DID NOT HAD A LONG ENOUGH OR FIRM ENOUGH AREA TO SECURE IT WITH SUTURE. THEY USED THEM YESTERDAY HAD A VERY DIFFICULT TIME TYING THE SECURING STITCH TIGHT ENOUGH TO HOLD IT WITHOUT CRIMPING THE DRAIN AND PREVENTING DRAIN FUNCTION. THE AREA WHERE IT WAS SUPPOSED TO BE SECURED WAS PROXIMAL TO THE BLACK DOT AND YET WAS SO SHORT THAT MINOR MOVEMENTS IN THE DRAIN WOULD CAUSE THE CHANNELS TO BE IN THE D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22203651 ↗
• MalfunctionFeb 23, 2023Suction Failure; Suction Failure

  IT WAS REPORTED THAT CUSTOMER USED A CHANNEL DRAIN DURING AN ABDOMINOPLASTY PROCEDURE. CUSTOMER CONNECTED IT TO A BULB SUCTION AND COULD VISUALLY SEE BLOOD IN THE DRAIN, BUT NONE WAS MOVING INTO THE BULB. IN FACT, THE BULB WAS ONLY STAY DEPRESSED FOR A COUPLE OF MINUTES, SO THEY CHANGED THE BULB BUT GOT THE SAME RESULTS. REPRESENTATIVE INFORMED CUSTOMER THAT THE MOST PROBABLE REASON FOR THIS WAS EITHER THE TUBING WAS COMPROMISED OUTSIDE THE INSERTION POINT OF THERE WAS NOT A GOOD SEAL AT THE WOUND SITE. THE DOCTOR REPORTED THAT THEY HAD SUTURED AROUND THE TUBING AT THE SITE AND FEELS CONFIDENT THERE WAS NOT ISSUE THERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16428860 ↗
• MalfunctionJan 13, 2023Component Missing; Component Missing

  IT WAS REPORTED THAT ONLY THREE DRAINS WERE INCLUDED IN THIS CASE, AND THE BOX DID NOT APPEAR DAMAGED OR RE-TAPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16156666 ↗
• InjuryApr 13, 2020Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT DURING A CHEST TUBE REMOVAL A "SNAP" WAS HEARD. THE TUBE BROKE APART AND A PORTION OF THE TUBE REMAINED INSIDE THE PATIENT'S CHEST. ANOTHER PROVIDER WAS NEEDED TO REMOVE THE RETAINED PIECE OF CHEST TUBE. PER ADDITIONAL INFORMATION THE REMOVAL OF THE RETAINED PIECE WAS COMPLETED DURING THE SAME PROCEDURE. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6)2020 VIA EMAIL FROM THE FACILITY THE CHEST TUBE WAS PLACED ON (B)(6)2020 AND WAS IN PLACE FOR (B)(4) DAYS POST MODIFIED CONE REPAIR OF THE TRICUSPID VALVE.

  Patient problems: Foreign Body In Patient

  MAUDE report 9954373 ↗
• InjuryMay 20, 2019Break

  IT WAS REPORTED THAT THE SILICONE CHANNEL DRAIN BROKE DURING REMOVAL LEAVING A PORTION INSIDE OF THE PATIENT. THE PATIENT REQUIRED ADDITIONAL SURGERY TO REMOVE THE FRAGMENT.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8624606 ↗
• MalfunctionJun 11, 2018Fluid/Blood Leak; Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE WOUND DRAIN LEAKED AT THE CONNECTION SITE WHERE THE DRAIN CONNECTED TO THE EVACUATOR.

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

  MAUDE report 7586469 ↗