Channel Drain 072191Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741049736), received between Feb 28, 2018 and Jul 1, 2026 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (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. 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.

• MalfunctionJul 1, 2026Material Too Rigid or Stiff

  IT WAS REPORTED THAT ACCORDING TO THE CLINICAL RESOURCE DIRECTOR, THEY ARE GETTING RECENT COMPLAINTS FROM MY SATILLA FACILITY THAT THE WOUND DRAINS WERE TOO STIFF. THE FACILITY AND DOCTORS THERE HAVE USED THESE SAME DRAINS FOR A WHILE NOW, SO THEY ARE NOT SURE WHAT HAD CHANGED. DRAINS ARE TOO STIFF FOR THE CURRENT STAFF, AND THEY WERE WONDERING IF THERE IS A LINE OF PERHAPS SOFTER MORE FLEXIBLE SILICONE DRAINS, THEY CAN HAVE THEM TRY UNTIL THIS IS RESOLVED. MATERIAL (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25677176 ↗
• InjuryNov 10, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DRAIN WAS PLACED IN A PATIENT ON (B)(6) FOLLOWING HEART SURGERY. ON (B)(6), DRAIN WAS PULLED PRIOR TO PATIENT BEING DISCHARGED HOME AND SEPARATED IN THE PATIENT RESULTING IN SURGICAL INTERVENTION TO REMOVE RETAINED DRAIN.

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

  MAUDE report 18110024 ↗
• MalfunctionJun 29, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE BARD SILICON DRAINS WERE FOUND TO BE BROKEN APART DURING DRAIN REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12085879 ↗
• InjuryJun 17, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT 3 BARD SILICON DRAINS BROKEN APART DURING DRAIN REMOVAL AFTER SURGICAL PLACEMENT. IN A COUPLE OF INSTANCES THE CUSTOMER COULD NOT RULE OUT THAT THE SURGEON INADVERTENTLY SUTURED THROUGH THE DRAIN BUT UNLIKELY. THE NURSE REPORTED NO RESISTANCE WHEN THE DRAIN WAS REMOVED BUT THE DRAIN PIECES HAD BEEN RETAINED AFTER REMOVAL REQUIRING RETURN TO THE OPERATING ROOM FOR REMOVAL. THE CUSTOMER REQUESTED TO KNOW WHETHER THEY HAD CHANGED THE DRAIN PRODUCTS SILICONE COMPOSITION QUALITY AND OTHER REPORTS OF BREAKING. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 01JUN2021 THE ONE OCCURRED AT (B)(6) HOSPITAL THE PATIENT HAD AN ELECTIVE HEMILAMINECTOMY ON (B)(6) 2021 AND LUMBAR DRAIN REMOVED AS PER PHYSICIAN ORDER BY ROOM NURSE ON (B)(6) 2021. THE SOFT TISSUE FOREIGN OBJECT WAS FOUND BY STANDARD X RAY PRIOR TO FOLLOW UP APPOINTMENT ON (B)(6) 2021. THE SURGERY FOR RETAINED LUMBAR WOUND SURGICAL DRAIN WAS TOLERATED WELL ON (B)(6) 2021 AND NO PATIENT HARM DETECTED. THE NOTIFICATION FROM THE OPERATING ROOM (OR) SCHEDULING TO REPORTING MANAGER THAT IT DID NOT OCCUR AS THE POLICY WAS NOT IN PLACE. THE DRAIN PART WAS DISCARDED AS IT DID NOT OCCUR TO INVOLVE THE STAFF AS THIS NEED

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

  MAUDE report 12014319 ↗
• InjuryJun 16, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT 3 BARD SILICON DRAINS WERE BROKEN APART DURING DRAIN REMOVAL, DAYS AFTER SURGICAL PLACEMENT. IN A COUPLE OF INSTANCES, THE CUSTOMER COULD NOT RULE OUT THAT THE SURGEON INADVERTENTLY SUTURED THROUGH THE DRAIN, BUT UNLIKELY. NURSES REPORTED NO RESISTANCE WHEN THE DRAIN WAS REMOVED, BUT THE DRAIN PIECES HAD BEEN RETAINED AFTER REMOVAL WHICH REQUIRED THE OPERATION ROOM TO GET IT REMOVED. AND THE CUSTOMER REQUESTED TO KNOW IF THEY HAD CHANGED THE DRAIN PRODUCTS, SILICONE COMPOSITION, QUALITY, OTHER REPORTS OF BREAKING. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON (B)(6) 2021, THE ONE THAT OCCURRED THE PATIENT HAD AN ELECTIVE HEMILAMINECTOMY AND LUMBAR DRAIN REMOVED BY ROOM NURSE PER PHYSICIAN ORDER. AND THE SOFT TISSUE FOREIGN OBJECT WAS FOUND ON X-RAY PRIOR TO FOLLOW UP APPOINTMENT. AND THE SURGERY FOR ¿RETAINED LUMBAR WOUND SURGICAL DRAIN¿ WAS TOLERATED WELL AND NO PATIENT HARM DETECTED. NOTIFICATION FROM OPERATING ROOM SCHEDULING DID NOT OCCUR AS THIS POLICY WAS NOT IN PLACE. DRAIN PART WAS DISCARDED AS IT DID NOT OCCUR TO INVOLVED STAFF THIS NEEDED TO BE PRESERVED, OVER READ SHOWED RETAINED PART WAS APPROX. 10CM LENGTH/15MM WIDTH. REMEDIED WITH EDUCATION AND

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

  MAUDE report 12011798 ↗
• InjuryJun 16, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT 3 BARD SILICON DRAINS WERE BROKEN APART DURING THE DRAIN REMOVAL, DAYS AFTER SURGICAL PLACEMENT. IN A COUPLE OF INSTANCES, THE CUSTOMER COULD NOT RULE OUT THAT THE SURGEON INADVERTENTLY SUTURED THROUGH THE DRAIN, BUT UNLIKELY. THE NURSES REPORTED NO RESISTANCE WHEN THE DRAIN WAS REMOVED, BUT THE DRAIN PIECES HAD BEEN RETAINED AFTER REMOVAL, WHICH REQUIRED THE OPERATION ROOM TO GET IT REMOVED. AND THE CUSTOMER REQUESTED TO KNOW IF THEY HAD CHANGED THE DRAIN PRODUCTS, SILICONE COMPOSITION, QUALITY, OTHER REPORTS OF BREAKING. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 01JUN2021, THE ONE THAT OCCURRED, THE PATIENT HAD AN ELECTIVE HEMILAMINECTOMY AND LUMBAR DRAIN REMOVED BY ROOM NURSE PER PHYSICIAN ORDER. AND THE SOFT TISSUE FOREIGN OBJECT WAS FOUND ON X-RAY PRIOR TO FOLLOW UP APPOINTMENT. AND THE SURGERY FOR ¿RETAINED LUMBAR WOUND SURGICAL DRAIN¿ WAS TOLERATED WELL AND NO PATIENT HARM DETECTED. NOTIFICATION FROM OPERATING ROOM SCHEDULING DID NOT OCCUR AS THIS POLICY WAS NOT IN PLACE. DRAIN PART WAS DISCARDED AS IT DID NOT OCCUR TO INVOLVED STAFF THIS NEEDED TO BE PRESERVED, OVER READ SHOWED RETAINED PART WAS APPROXIMATELY 10 CM LENGTH/15 MM WIDTH. REMEDIED WI

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

  MAUDE report 12011791 ↗
• MalfunctionMar 23, 2021Disconnection; Material Fragmentation; Disconnection; Material Fragmentation

  IT WAS REPORTED THAT THE BARD SILICONE CHANNEL DRAIN WAS DEFECTIVE. IT WAS UNKNOWN WHAT THE EXACT DEFECT. PER FOLLOW UP VIA EMAIL ON 03MAR2021 IT WAS STATED THAT THE 19 FR RD FULL FLUTE DRAIN WAS BROKEN WHEN TRIED TO THREAD THROUGH. NO MEDICAL INTERVENTION REQUIRED AND NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11554338 ↗
• MalfunctionFeb 28, 2018Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE DRAIN APPEARED TO BE SMALLER THAN 19FR. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7302766 ↗