Channel Drain 072225Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741049859), received between Aug 25, 2017 and Feb 25, 2025 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2025Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE PREVIOUS ISSUES OF CHANNEL DRAIN TROCARS BEING DULL AND NOT DRAINING AS EFFECTIVE HAD STAYED PERSISTENT AND THEY WERE LOOKING TO CONVERT TO CARDINAL DRAINS BECAUSE A PATIENT HAD BEEN HARMED. THE CUSTOMER HAD NOT YET ELABORATED ON HOW THE PATIENT WAS HARMED OR IN WHAT WAY. THEY SPOKE WITH CUSTOMER TO (B)(6) TO TRY TO GET AN UNDERSTANDING OF WHY THEY WERE SHIFTING OVER TO CARDINAL FROM BARD, AND THEY EXPLAIN THAT THE ISSUES THAT CAME INTO ADDRESSED AND WORK ON HAD REMAINED PERSISTENT (DULL TROCARS AND WEAK DRAINING) ACCORDING TO THE SURGEONS. IT WAS STATED THAT THE PATIENT GOT HURT DUE TO ONE OF THE PRODUCTS, SO THEY HAVE TO CONVERT THEIR EXISTING SKUS. THE CUSTOMER SPOKE TO THEIR COORDINATOR ABOUT MORE INFORMATION REGARDING THE DRAIN ISSUES. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 21458816 ↗
• MalfunctionOct 16, 2023Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT UNTIL THEN, THE 19FR CHANNEL DRAIN COULD BE CONNECTED TO A 5MM ABDOMINAL PORT WITHOUT ANY PROBLEM, BUT THAT TIME IT COULD NOT BE CONNECTED. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 10OCT2023, THE CUSTOMER CONFIRMED THAT IT WAS A FITTING PROBLEM.

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

  MAUDE report 17940695 ↗
• InjuryDec 5, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE DRAIN BAG TUBING BROKE OFF. IT WAS STATED THAT LESS THAN AN INCH OF TUBE WAS STUCK OUT OF THE PATIENT AND REPORTING NURSE MANAGED TO HOLD THE TUBE OUTSIDE OF SKIN WITH TWEEZERS UNTIL CHARGE NURSE COULD GET TO ROOM. HEMOSTATS WERE USED AND THE REST OF THE TUBE WAS REMOVED INTACT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body In Patient

  MAUDE report 15915729 ↗
• MalfunctionMay 9, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS WHITE FOREIGN MATERIAL WHEN THE WOUND DRAINAGE PACKAGE WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14336282 ↗
• InjuryJun 3, 2019Break; Disconnection; Break; Disconnection; Material Fragmentation

  IT WAS REPORTED THAT THE CHANNEL DRAIN WAS PLACED IN THE PATIENT IN (B)(6) OF 2018. A PORTION WAS LEFT IN THE PATIENT AND WAS DISCOVERED VIA A CT SCAN PERFORMED ON THE PATIENT DUE TO HAVING CHEMOTHERAPY. THE WHITE PORTION THAT WAS DISCOVERED WAS REMOVED IN (B)(6) OF 2019. DURING THE TIME THAT BROKEN PIECE WAS LEFT IN THE PATIENT; THERE WERE NO SIGNS OR SYMPTOMS OF THE DEVICE BEING LEFT INSIDE OF THE PATIENT DURING THIS TIMEFRAME.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 8663221 ↗
• InjuryAug 25, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IN (B)(6) 2017, A PATIENT HAD AN INGUINAL HERNIA REPAIR. IN (B)(6) 2017, THE BOWEL WAS IMPACTED AND AN ILEUS WAS FORMED. A CHANNEL DRAIN WAS PLACED TO HELP DRAIN THE WOUNDS AROUND THE ILEUM. NO ABNORMALITIES SUCH AS, DEVICE DAMAGE OR OCCLUSION WERE OBSERVED AFTER PLACEMENT. HOWEVER, ON (B)(6) 2017, THE NINTH DAY OF PLACEMENT, THE OUTFLOW OF INTESTINAL FLUID THROUGH THE CHANNEL DRAIN WAS FOUND. THERE WAS AN INCISIONAL INFECTION CAUSED BY A BOWEL PERFORATION. THE FACILITY STATED THAT THE CHANNEL DRAIN MAY HAVE ADHERED TO THE POST-SURGICAL BOWEL RELATING TO THIS EVENT. AN ADDITIONAL SURGERY WAS DONE WHERE A COLOSTOMY WAS PLACED. IT WAS LATER REPORTED THAT THE COLOSTOMY IS TEMPORARY AND WILL BE REMOVED AS SOON AS THE WOUND RECOVERS.

  Patient problems: Bowel Perforation; Unspecified Infection

  MAUDE report 6822069 ↗