Silicone Flat Drain 0070360Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741090738), received between Dec 6, 2022 and Oct 20, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 20, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE CUSTOMER STATED FOREIGN MATTER (INSIDE THE STERILIZED PACKAGE), FRACTIONAL GOOD PRODUCT, BIOLOGICAL MATTER (INSIDE THE STERILIZED PACKAGE) FOREIGN MATTER (OUTSIDE THE STERILIZED PACKAGE) BIOLOGICAL MATTER (INSIDE THE STERILIZED PACKAGE) FRACTIONAL GOOD PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23335348 ↗
• MalfunctionOct 17, 2025Device Contamination with Chemical or Other Material; Device Contaminated During Manufacture or Shipping; Device Contamination with Chemical or Other Material; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE CUSTOMER STATED FOREIGN MATTER (INSIDE THE STERILIZED PACKAGE) FRACTIONAL GOOD PRODUCT BIOLOGICAL MATTER (INSIDE THE STERILIZED PACKAGE) FOREIGN MATTER (OUTSIDE THE STERILIZED PACKAGE) BIOLOGICAL MATTER (INSIDE THE STERILIZED PACKAGE) FRACTIONAL GOOD PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23328401 ↗
• MalfunctionSep 23, 2025Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT ON 16SEP2025, WHEN THE WOUND DRAIN PRODUCT WAS OPENED IN THE OPERATING ROOM, A BURR WAS FOUND, AND IT WAS DISCONTINUED. WHEN A PRODUCT FROM THE SAME LOT WAS OPENED, A BURR WAS ALSO FOUND, AND IT WAS DISCONTINUED FROM USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23123078 ↗
• MalfunctionDec 9, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THERE WAS A FRAYED EDGE ON THE TIP OF THE WOUND DRAIN, THE SIDE THAT WAS LEFT INSIDE THE BODY. THERE WAS DAMAGE TO THE TIP OF THE DRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20878931 ↗
• MalfunctionOct 1, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT WHEN THE WOUND DRAIN WAS OPENED IN THE OPERATING ROOM FOR USE, A FOREIGN OBJECT WAS FOUND IN IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20346085 ↗
• MalfunctionFeb 14, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT HAIR MIXED IN STERILE BAG OF WOUND DRAIN DEVICE. PER INTERNAL COMMENTS RECEIVED ON 30JAN2024, IT WAS CONFIRMED THAT IT WAS UNOPENED. THEY CONFIRMED THAT THERE WAS A FOREIGN OBJECT IN THE STERILIZED BAG. INSIDE THE BAG CONTAINING THE PRODUCT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18702179 ↗
• MalfunctionSep 27, 2023Material Fragmentation; Component Misassembled; Material Fragmentation; Component Misassembled

  IT WAS REPORTED THAT WHEN CHECKING THE WOUND DRAINAGE BEFORE USE, THE END OF THE TUBE WAS FOUND TO BE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17825534 ↗
• MalfunctionAug 18, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE THIN SIDE OF THE WOUND DRAINAGE BLUE CONNECTOR WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17571996 ↗
• MalfunctionApr 13, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A FOREIGN MATERIAL WAS MIXED IN THE WOUND DRAIN DEVICE. THE CUSTOMER REQUESTED TO CONFIRM WHETHER THAT FOREIGN MATERIAL WAS A PIECE OF DRAIN TUBE OR NOT. PER FOLLOW-UP INFORMATION RECEIVED FROM IBC ON 30MAR2023, STATED THAT THE DEFECT WAS FOUND AFTER USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16731619 ↗
• MalfunctionDec 6, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THE CONNECTOR WAS MISSING IN THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15923927 ↗