Channel Drain 072211Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00801741049767), received between Aug 8, 2018 and Aug 21, 2025 — classified as 5 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Restricted Flow rate” (5 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 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 22865788 ↗
• InjuryNov 22, 2024Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE PATIENT HAD C2-C6 DECOMPRESSION AND FUSION SURGERY THAT WAS UNCOMPLICATED. HOWEVER, THEIR EPIDURAL DRAIN NEVER HAD ANY OUTPUT (LOT #NGHZ1245). A POST-OP CT SCAN DID NOT SHOW A FLUID COLLECTION AND CLINICALLY THEY NOTED AN IMPROVING CLINICAL COURSE WITH DECREASED NUMBNESS IN THEIR HANDS. ON POD#4 (POSTOPERATIVE DAY), THEY REPORTED INCREASING PAIN AND WAS GIVEN A MUSCLE RELAXANT. THIS DID NOT HELP, AND THEY PRESENTED TO THE EMERGENCY DEPARTMENT WITH WORSENING NUMBNESS, PAIN AND POSSIBLE WEAKNESS, ALTHOUGH OBJECTIVE EXAM WAS VERY CLOSE TO THEIR POST-OP BASELINE. A MAGNETIC RESONANCE IMAGING OF THE C-SPINE SHOWED AN EPIDURAL FLUID COLLECTION WITH CORD COMPRESSION. THE PATIENT UNDERWENT EVACUATION. OTHER CHANNEL DRAIN WITH PCN # 072212 WAS ALSO INVOLVED (LOT #NGJP3050).

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

  MAUDE report 20757057 ↗
• MalfunctionNov 11, 2024Decrease in Suction; Decrease in Suction

  IT WAS REPORTED THAT THEY HAD EXPERIENCED DEFECTIVE WOUND DRAINS IN PATIENT CARE AND NEED TO RESOLVE THIS ISSUE AS SOON AS POSSIBLE. THE REPORT INDICATED DRAINS WERE NOT FUNCTIONING CORRECTLY AND POSING A RISK TO THE PATIENT. THE AFFECTED LOTS THEY HAD ENCOUNTERED SO FAR WERE (LOT #NGHZ1245) AND (LOT #NGJP3050), WHICH THEY HAD PULLED 2 CASES OF AFFECTED OFF THE SHELF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20651661 ↗
• MalfunctionNov 11, 2024Decrease in Suction; Decrease in Suction

  IT WAS REPORTED THAT THEY HAD EXPERIENCED DEFECTIVE WOUND DRAINS IN PATIENT CARE AND NEED TO RESOLVE THIS ISSUE AS SOON AS POSSIBLE. THE REPORT INDICATED DRAINS WERE NOT FUNCTIONING CORRECTLY AND POSING A RISK TO THE PATIENT. THE AFFECTED LOTS THEY HAD ENCOUNTERED SO FAR WERE (LOT #NGHZ1245 AND LOT #NGJP3050), WHICH THEY HAD PULLED 2 CASES OF AFFECTED OFF THE SHELF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20651408 ↗
• InjuryNov 6, 2024Suction Failure; Suction Failure

  IT WAS REPORTED THAT WOUND DRAIN WAS USED FOR A SPINE CASE. IT APPEARED TO NOT BE PATENT AND WOULD NOT DRAIN THE FLUID FROM THE SURGICAL WOUND. AFTER OPENING THE WOUND AND REMOVING THE DRAIN FROM THE PATIENT, THE DRAIN WOULD NOT FLUSH AND STAYED COMPRESSED IN OPEN AIR. ONE PATIENT HAD TO BE TAKEN BACK TO THE OPERATING ROOM (OR). THIS WAS A MAJOR SAFETY ISSUE. THE RESIDENT SAID THIS WAS THE THIRD TIME THEY HAD THIS EXPERIENCE (LOT#NGHZ1245, LOT#NGJP3050 AND LOT#UNK).

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

  MAUDE report 20621551 ↗
• InjuryNov 6, 2024Suction Failure; Suction Failure

  IT WAS REPORTED THAT WOUND DRAIN THAT WAS USED FOR A SPINE CASE. IT APPEARED TO NOT BE PATENT AND WOULD NOT DRAIN THE FLUID FROM THE SURGICAL WOUND. AFTER OPENING THE WOUND AND REMOVING THE DRAIN FROM THE PATIENT, THE DRAIN WOULD NOT FLUSH AND STAYED COMPRESSED IN OPEN AIR. ONE PATIENT HAD TO BE TAKEN BACK TO THE OPERATING ROOM (OR). THIS WAS A MAJOR SAFETY ISSUE. THE RESIDENT SAID THIS WAS THE THIRD TIME THEY HAD THIS EXPERIENCE (LOT#NGHZ1245, LOT#NGJP3050 AND LOT#UNK).

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

  MAUDE report 20621274 ↗
• MalfunctionOct 3, 2024Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT DOCTOR PERFORMED A RECONSTRUCTION LATISSIMUS DORSI FLAP BREAST PROCEDURE ON (B)(6) 2024 AND CALLED LATER THAT EVENING REPORTING THAT THE DRAIN FAILED. THIS HAS ALLEGEDLY HAPPENED AN UNSPECIFIED NUMBER OF TIMES IN THE PAST, BUT THEY DID NOT HAVE DETAILS ON THOSE OCCURRENCES. A SINGLE DRAIN WAS MARKED AS USED IN BILLING, HOWEVER PER DOCTOR¿S CONVERSATION WITH THEM AND THE OPERATIVE NOTE, THERE WERE 4 DRAINS PLACED. THE DRAINS WERE NOT CHARTED INTO THE IMPLANT LOG, NOR WAS THE LOT NUMBER OF THE 4 DRAINS RECORDED ANYWHERE ELSE THAT THEY COULD IDENTIFY. THEN THE DOCTOR CONFIRMED THAT THEY COULD NOT BE FLUSHED (DATE OF EVENT - 04SEP2024), (DATE OF EVENT- UNK). ACCORDING TO THE DOCTOR THE DRAINS WERE NOT FLUSHING WELL, AND THEY ARE HAVING TO USE MULTIPLE DRAINS DURING ONE PROCEDURE. THEY WERE LOOKING FOR RECOMMENDATIONS FOR A DRAIN THAT MIGHT WORK BETTER. THEY QUESTIONED WHETHER IT WAS A SIZE ISSUE AND SO MOVING UP TO THE PCN #072214 MIGHT WORK BETTER OR ANY OTHER DRAIN THEY COULD SUGGEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20358399 ↗
• MalfunctionOct 3, 2024Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT DOCTOR PERFORMED A RECONSTRUCTION LATISSIMUS DORSI FLAP BREAST PROCEDURE ON (B)(6) 2024 AND CALLED LATER THAT EVENING REPORTING THAT THE DRAIN FAILED. THIS HAS ALLEGEDLY HAPPENED AN UNSPECIFIED NUMBER OF TIMES IN THE PAST, BUT THEY DID NOT HAVE DETAILS ON THOSE OCCURRENCES. A SINGLE DRAIN WAS MARKED AS USED IN BILLING, HOWEVER PER DOCTOR¿S CONVERSATION WITH THEM AND THE OPERATIVE NOTE, THERE WERE 4 DRAINS PLACED. THE DRAINS WERE NOT CHARTED INTO THE IMPLANT LOG, NOR WAS THE LOT NUMBER OF THE 4 DRAINS RECORDED ANYWHERE ELSE THAT THEY COULD IDENTIFY. THEN THE DOCTOR CONFIRMED THAT THEY COULD NOT BE FLUSHED (DATE OF EVENT - 04SEP2024), (DATE OF EVENT - UNK). ACCORDING TO THE DOCTOR THE DRAINS WERE NOT FLUSHING WELL, AND THEY ARE HAVING TO USE MULTIPLE DRAINS DURING ONE PROCEDURE. THEY WERE LOOKING FOR RECOMMENDATIONS FOR A DRAIN THAT MIGHT WORK BETTER. THEY QUESTIONED WHETHER IT WAS A SIZE ISSUE AND SO MOVING UP TO THE PCN #072214 MIGHT WORK BETTER OR ANY OTHER DRAIN THEY COULD SUGGEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20358270 ↗
• MalfunctionSep 30, 2024Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT DOCTOR PERFORMED A RECONSTRUCTION LATISSIMUS DORSI FLAP BREAST PROCEDURE ON (B)(6) 2024 AND CALLED ANOTHER PERSON LATER REPORTING THAT THE DRAIN FAILED. THIS HAS ALLEGEDLY HAPPENED AN UNSPECIFIED NUMBER OF TIMES IN THE PAST. ACCORDING TO DOCTOR THEY CANNOT BE FLUSHED. THEY HAVE TO USE MULTIPLE DRAINS IN THE PROCEDURE INSTEAD OF JUST ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20334353 ↗
• MalfunctionSep 30, 2024Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT DOCTOR PERFORMED A RECONSTRUCTION LATISSIMUS DORSI FLAP BREAST PROCEDURE ON (B)(6) 2024 AND CALLED ANOTHER PERSON LATER REPORTING THAT THE DRAIN FAILED. THIS HAS ALLEGEDLY HAPPENED AN UNSPECIFIED NUMBER OF TIMES IN THE PAST. ACCORDING TO DOCTOR THEY CANNOT BE FLUSHED. THEY HAVE TO USE MULTIPLE DRAINS IN THE PROCEDURE INSTEAD OF JUST ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20333585 ↗
• MalfunctionJul 18, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE CUSTOMER WAS HAVING MAJOR DIFFICULTIES WITH THE INSERTION AND REMOVAL OF THIS WOUND DRAIN, CAUSING TWO PATIENTS TO RETURN TO THE OPERATING ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15040592 ↗
• MalfunctionJul 15, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE CUSTOMER WAS HAVING MAJOR DIFFICULTIES WITH THE INSERTION AND REMOVAL OF THIS WOUND DRAIN, CAUSING TWO PATIENTS TO RETURN TO THE OPERATING ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15029101 ↗
• InjuryMar 26, 2020Break; Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A PIECE OF THE WOUND DRAIN BROKE OFF IN THE PATIENT DURING A LUMBER SPINAL WOUND DEHISCENCE PROCEDURE, TO PREVENT POSSIBLE DEEP SPACE INFECTION. THE PATIENT RECEIVED ADDITIONAL SURGERY TO REMOVE THE MATERIAL, AND WAS RELEASED FROM (B)(6) HOSPITAL.

  Patient problems: Foreign Body In Patient; Wound Dehiscence

  MAUDE report 9885255 ↗
• InjuryAug 8, 2018Break; Entrapment of Device; Physical Resistance/Sticking

  IT WAS REPORTED THAT A UPON REMOVAL OF THE BULB DRAIN, THE REGISTERED NURSE WAS UNABLE TO REMOVE THE DRAIN. THE SURGEON ATTEMPTED TO REMOVE THE DRAIN. THE FLUTED PART OF THE DRAIN BROKE OFF INSIDE THE PATIENT. SURGERY WAS DONE TO REMOVE THE FOREIGN BODY THAT WAS UNDERNEATH THE CERVICAL FASCIA. ONE THIRD OF THE STAPLES HAD TO BE REMOVED TO RETRIEVE THE BROKEN PIECE. THE WOUND WAS IRRIGATED AND RECLOSED, AND THE PATIENT WAS DISCHARGED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7761380 ↗