DeRoyal 89-10536Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00749756364003), received between Oct 8, 2021 and Mar 20, 2023 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  A HAIR FOUND IN THE BLUE TOWEL OF CAROTID PACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16573811 ↗
• MalfunctionDec 14, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  STERILE SUCTION TUBING HAD UNKNOWN CONTAMINANT ON IT. BACK TABLE BROKEN DOWN AND NEW SET UP DONE BY SCRUB NURSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15976918 ↗
• MalfunctionNov 29, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  SUBSTANCE ON THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15876839 ↗
• MalfunctionAug 11, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  RED SUBSTANCE ON SUCTION TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15209596 ↗
• MalfunctionJul 6, 2022Component Misassembled; Component Misassembled

  DEROYAL CMC AV FISTULA PACK CONTAINS 4-0 SILK TIES INSTEAD OF 2-0 SILK TIES AS STATED ON THE PACKING LIST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14930581 ↗
• MalfunctionJun 16, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  SUCTION TUBING HAS DISCOLORATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14715717 ↗
• MalfunctionMay 6, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  RED SUBSTANCE ON TUBING. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14304032 ↗
• MalfunctionFeb 22, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  PACK CONTAINED SUCTION TUBING THAT APPEARED TO HAVE A BROWNISH SUBSTANCE ON WHAT LOOKS LIKE THE OUTSIDE OF THE TUBING. THE PATIENT WAS NOT IN THE ROOM. THE OFFENDING ITEM ALONG WITH THE ENTIRE PACK WAS REMOVED. A NEW PACK WAS BROUGHT IN AND CAREFULLY INSPECTED PRIOR TO BRINGING THE PATIENT IN THE ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13578076 ↗
• MalfunctionOct 8, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  SPECK OF DUST FOUND IN THE (CMC AV FISTULA PACK). IT WAS FOUND BEFORE THE PATIENT GOT IN THE ROOM. THE PACK WAS CLOSED AND THROWN AWAY. INFORMATION WAS RECEIVED FROM THE UNIT DIRECTOR THE STAFF STATED PARTICLES WAS NOTED ON THE LEFT SIDE OF PACK AFTER OPENING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12598476 ↗