Channel Drain 072230Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741049903), received between May 1, 2017 and Jul 24, 2025 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE CUSTOMER CALLED TO REPORT THAT THEY OPENED THE WOUND DRAIN AND FOUND HAIR IN THE SEALED PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22588756 ↗
• MalfunctionMar 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THEY WERE HAVING SOME ISSUES WITH A FEW OF THEIR WOUND DRAINS THAT THEY HAD CONVERTED FROM CARDINAL TO BARD. PHYSICIANS WERE CONCERNED ABOUT THE BARD DRAIN NOT BEING TAPERED (PCN #072227), (PCN #072229), (PCN #072230) AND THEY WERE HAVING ISSUES WITH IT STAYING IN CORRECTLY. THE BARD ITEM NUMBERS THAT THEY WERE EXPERIENCING ISSUES WITH WERE: (PCN #072227), (PCN #072229), (PCN #072230).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21584405 ↗
• MalfunctionFeb 28, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THEY WERE HAVING SOME ISSUES WITH A FEW OF THEIR WOUND DRAINS THAT HAVE CONVERTED FROM CARDINAL TO BARD. PHYSICIANS WERE CONCERNED ABOUT THE BARD DRAIN NOT BEING TAPERED AND THEY WERE HAVING ISSUES WITH IT STAYING IN CORRECTLY. THE BARD ITEM NUMBERS THAT WE ARE EXPERIENCING ISSUES WITH ARE: (PCN#: 072227), (PCN#: 072229), (PCN#: 072230).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21491892 ↗
• MalfunctionDec 31, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A WOUND DRAIN AND THERE WAS A HAIR IN THE PACKAGE. PER CUSTOMER VIA EMAIL ON 15JAN2025. CUSTOMER REPORTED THAT THE SAMPLE WAS ALREADY SENT BACK. THE PRODUCT WAS NOT USED ON THE PATIENT AND THE HAIR WAS FOUND BEFORE OPENING ONTO THE STERILE FIELD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21047024 ↗
• InjuryDec 2, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT PATIENT HAD AN INITIAL LAMINECTOMY ON 2024 WITH A JP DRAIN PLACEMENT AND STATED IN 2024 THE DRAIN WAS REMOVED PRIOR TO DISCHARGE. POSTOP CT DEMONSTRATED A PORTION OF THE DRAIN WAS RETAINED. THE PATIENT WAS ADMITTED 2024 AND WENT TO SURGERY FOR REMOVAL OF STATED DRAIN. THE PORTION OF THE DRAIN WAS SENT TO LAB FOR GROSS ANALYSIS.

  Patient problems: Foreign Body In Patient

  MAUDE report 20818389 ↗
• MalfunctionFeb 14, 2023Illegible Information; Illegible Information

  IT WAS REPORTED THAT THE NURSE FELT THERE SHOULD BE LANGUAGE ON PE50305 THAT STATED THE INNER ENVELOPE WAS STERILE. BD REPRESENTATIVE EXPLAINED THEY SHOULD BE ABLE TO SEE THE STERILE/EO LANGUAGE ON THE INNER POUCH (PK7659674) THROUGH THE WINDOW ON THE OUTER POUCH. ALSO STATED IT WAS NOT EASY TO SEE THIS PART OF THE LABELING THROUGH THE WINDOW AND CONTENDS IT SHOULD ALSO BE PRINTED ON THE OUTER POUCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16371316 ↗
• InjuryNov 7, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE CORONARY ARTERY BYPASS GRAFT SURGERY (CABG) PATIENT HAD CHANNEL DRAIN PLACED IN THE RIGHT PLEURAL SPACE ON 04OCT2021. ON 06OCT2021, THE PHYSICIAN DISCONTINUED THE DRAIN. DURING ROUTINE REMOVAL, THE TUBE BROKE INTO TWO PIECES, LEAVING A PORTION OF THE TUBE INSIDE OF THE PATIENT. THE PATIENT HAD SURGERY NEXT DAY TO REMOVE THE RETAINED PORTION. THE SEPARATION OF THE TWO PIECES WERE JAGGED AND UNEVEN. IT BROKE ABOUT 1 INCH ABOVE THE BLACK DOT THAT WAS LOCATED TOWARDS THE BOTTOM OF THE DRAIN. NURSE REPORTED THAT IT WAS A ROUTINE REMOVAL WITH NORMAL RESISTANCE, AND IT WAS EASILY REMOVED UNTIL IT BROKE. PATIENT HAD BEEN DOING WELL AND WAS EXPECTED TO CONTINUE BUT AFTER THE SURGERY TO REMOVE THE RETAINED CHANNEL DRAIN, THE PATIENT HAD NOT DONE WELL. PHYSICIAN INDICATED THE ADDITIONAL ANESTHESIA REQUIRED FOR THE SURGERY MAY HAVE AFFECTED THE PATIENT CONDITION. PATIENT WAS INSULIN DEPENDENT DIABETIC, ON HEMODIALYSIS, HISTORY OF AMPUTATION OF LOWER EXTREMITY AND OTHER CO-MORBIDITIES. PATIENT IS CURRENTLY IN ICU ON VENTILATOR. PER FORM RECEIVED ON 27OCT2021, STATED THAT THERE WAS A SURGICAL REMOVAL OF RETAINED TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12761165 ↗
• MalfunctionNov 20, 2020Partial Blockage; Component Misassembled; Partial Blockage; Component Misassembled

  IT WAS REPORTED THAT THE DRAIN WAS BLOCKED AND NOT DRAINED. SUPPOSEDLY, WHEN THE DRAIN WAS REMOVED, IT WAS NOTED THAT THE CHANNEL IN THE DRAIN WAS GELATINIZED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10876536 ↗
• InjuryDec 7, 2017Break

  IT WAS REPORTED THE DRAIN BROKE WHILE BEING REMOVED.

  Patient problems: No Information

  MAUDE report 7094913 ↗
• MalfunctionJun 1, 2017Incorrect Measurement

  IT WAS REPORTED THAT THE DRAIN APPEARED TO BE THE WRONG SIZE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6606023 ↗
• MalfunctionMay 2, 2017Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE DRAIN CHANNEL WAS THE WRONG SIZE, AS IT ALLEGEDLY APPEARED TO BE LARGER THAN 19FR.. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NOT YET RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6538824 ↗
• MalfunctionMay 1, 2017Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE CHANNELS SEEMED TO BE SHORTER THAN USUAL. THE DRAIN CHANNEL WAS INSERTED AND WORKED FINE; HOWEVER, IT WAS USUALLY LONGER. NO MEDICAL INTERVENTION WAS NEEDED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6534577 ↗