Channel Drain 072214Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741049798), received between Feb 13, 2019 and Sep 17, 2026 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Nonstandard Device

  It was reported that Methodist Hospital OR has been using our wound drains as an alternative to their usual wound drains. The item numbers are the exact same, but the quality was poor. The hub where the channel meets the drain seems to be thicker than normal and has caused 3 hematomas. No medical intervention was reported.

  Patient problems: Hematoma

  MAUDE report 50802887 ↗
• MalfunctionAug 15, 2025Defective Device; Device Contamination with Chemical or Other Material; Defective Device; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AN ADDITIONAL COMPLAINTS HAVE BEEN REPORTED REGARDING THE SAME ITEM, AND IT HAS BEEN IDENTIFIED THAT THE ISSUE MAY AFFECT MULTIPLE ITEMS BEYOND THE ORIGINALLY REPORTED 072221. A MEETING IS REQUESTED TO DISCUSS THE ISSUE FURTHER. CONSIDERATION IS BEING GIVEN TO REMOVING THE AFFECTED PRODUCT AND RELATED ITEMS FROM INVENTORY UNTIL CONFIRMATION OF RESOLUTION IS OBTAINED. IMPACTED ITEMS INCLUDE: 072211. 072190. 072189. 072214. 072186. ADDITIONAL REPORTS DATED (B)(6) FROM THE CUSTOMER ARE INCLUDED BELOW. COMMUNICATION FROM (B)(6) WAS SUBMITTED AND DOCUMENTED UNDER PR (B)(4) AND (B)(4), WITH CUSTOMER OUTREACH PENDING. NEW REPORTS SHOULD BE REVIEWED TO CONFIRM ALIGNMENT WITH PREVIOUSLY OPENED RECORDS. ENSURE INCLUSION OF BD CUSTOMER QUALITY AND RELEVANT STAKEHOLDERS IN ALL CUSTOMER COMMUNICATIONS. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 14AUG2025, IT WAS REPORTED THAT THEY SHARED CLINICIANS RAISED MULTIPLE CONCERNS RELATED TO ITEM 072221 AND THEN INSPECTED SIMILAR ITEMS AT THEIR DISTRIBUTION CENTER AND FOUND FUZZY HAIR FOREIGN MATTER IN THOSE ITEMS AS WELL. THERE WAS NO HARM TO A PATIENT AS THESE WERE FOUND BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22816273 ↗
• MalfunctionAug 12, 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 INSER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22784168 ↗
• InjuryJan 18, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE WOUND DRAIN SUDDENLY SNAPPED WITHOUT PENROSE DRAIN PORTION EXITING THE SKIN AND THUS LEAVING REMAINDER OF DRAIN WITH THE PATIENT. STATED THAT THE DOCTOR ASSESSED THE SITE UNABLE TO LOCATE REMAINDER OF DRAIN, SO THE PATIENT WAS BROUGHT TO THE OPERATING ROOM TO HAVE THE EMBEDDED PORTION OF THE DRAIN REMOVED. AS PER SAMPLE FORM RECEIVED ON 13JAN2023, THE CUSTOMER STATED THAT WHEN WOUND DRAIN REMOVED ON (B)(6) 2022 IT SUDDENLY SNAPPED WITHOUT PENROSE DRAIN PORTION EXITING THE SKIN AND THUS LEAVING REMAINDER OF DRAIN WITH THE PATIENT. STATED THAT THE DOCTOR ASSESSED THE SITE UNABLE TO LOCATE REMAINDER OF DRAIN, SO THE PATIENT WAS BROUGHT TO THE OPERATING ROOM FOR REMOVAL. PATIENT HAD A SURGERY TO REMOVE BROKEN DEVICE OUT OF BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 16195633 ↗
• MalfunctionFeb 13, 2019Break; Break

  IT WAS REPORTED THAT THE WOUND DRAIN BROKE APART WHERE THE 2 PIECES CONNECT TOGETHER, DURING AN ATTEMPT TO INSERT INTO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8337325 ↗