Channel Drain V072231Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741119200), received between Dec 28, 2018 and Sep 4, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Wrong Label” (7 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.

• MalfunctionSep 4, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT THE WOUND DRAIN BAG ARE LABELED AS 19F, BUT THEY ARE ACTUALLY 15F DRAINS. SAMPLE IS AVAILABLE FOR RETURN. NO PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22965814 ↗
• MalfunctionMar 18, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT CUSTOMER RECEIVED SOME DRAINS THAT WERE THE WRONG SIZE. REPRESENTATIVE BELIEVED CUSTOMER RECEIVED EITHER 19 IN A 15 PACKAGE OR 15 IN THE 19 FRENCH PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21631143 ↗
• MalfunctionMar 3, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT WOUND DRAIN LABELED AS 19FR DRAIN. ACTUAL DRAIN IN PACKAGING WAS A 15FR DRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21504220 ↗
• MalfunctionFeb 21, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT THE WOUND DRAIN LABELED AS 19 FR DRAIN AND INCORRECT DRAIN IN STERILE PACKAGING. THIS WAS NOT FIRST OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21432092 ↗
• MalfunctionFeb 20, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT CUSTOMER WENT TO OPEN THE PACKAGE FOR A 19FR WOUND DRAIN BUT WHEN OPENED THEY WERE FINDING A 15FR. PER ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 3, 2025, IT WAS REPORTED THAT THE PARTICULAR WOUND DRAIN HAD BEEN OPENED TO THE STERILE FIELD FOR PATIENT USE, AND UPON PHYSICAL TOUCH, IT WAS NOTICED THAT THE DRAIN WAS THE WRONG SIZE (LOT #: NGJV0169). THE DRAIN NEVER MADE IT IN THE PATIENT AND THE DEVICE WAS REPLACED PRIOR TO INSERTION. MULTIPLE 19FR DRAINS HAD BEEN LABELED AS 19FR AND UPON OPENING, IT WAS A 15FR. THEY HAD DIFFERENT LOT NUMBERS (LOT #: UNK).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21424079 ↗
• MalfunctionFeb 18, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT THEY WANTED MADE THEM AWARE OF A SITUATION THAT CAME TO THEIR ATTENTION YESTERDAY REGARDING BARD DRAIN V072231 OR 084426. DOCTOR NOTIFIED THEM THE PACKAGING ON THE PRODUCT HAD BEEN LESS THAN ACCURATE APPROXIMATE 50% OF THE TIME. THE PACKAGING STATES 19 FR. DRAIN AND THE DRAIN WAS ACTUALLY A 15 FR, THEY HAD TO THROW AWAY AND OPEN A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21405446 ↗
• MalfunctionFeb 14, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT CUSTOMER WENT TO OPEN THE PACKAGE FOR A 19FR WOUND DRAIN BUT WHEN OPENED THEY WERE FINDING A 15FR. PER ADDITIONAL INFORMATION RECEIVED ON 03FEB2025, IT WAS REPORTED THAT THE PARTICULAR WOUND DRAIN HAD BEEN OPENED TO THE STERILE FIELD FOR PATIENT USE, AND UPON PHYSICAL TOUCH, IT WAS NOTICED THAT THE DRAIN WAS THE WRONG SIZE (LOT#NGJV0169). THE DRAIN NEVER MADE IT IN THE PATIENT AND THE DEVICE WAS REPLACED PRIOR TO INSERTION. MULTIPLE 19FR DRAINS HAD BEEN LABELED AS 19FR AND UPON OPENING, IT WAS A 15FR. THEY HAD DIFFERENT LOT NUMBERS (LOT#UNK).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21384107 ↗
• InjuryDec 28, 2018Break; Entrapment of Device

  IT WAS REPORTED THAT WHEN THE SURGEON ATTEMPTED TO REMOVE THE CHANNEL DRAIN AFTER AN "ABOVE KNEE AMPUTATION," THE DRAIN BROKE OFF IN THE PATIENT'S LEG. THE COMPLAINANT REPORTED THAT THE PATIENT HAD TO RETURN TO THE OR TO HAVE THE BROKEN PIECE OF THE DRAIN RETRIEVED. THE BROKEN FRAGMENT REPORTEDLY CAME OUT IN ONE PIECE.

  Patient problems: Foreign Body In Patient

  MAUDE report 8204178 ↗