Toomey Syringe 0038460Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741049316), received between Aug 9, 2018 and Feb 16, 2022 — classified as 9 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 18, 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.

• MalfunctionFeb 16, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CUSTOMER NEEDED TOOMEY IRRIGATION SYRINGE WITH A CAP. STATED THAT THEY PLACED BARIUM IN IT AND WAS LEAKING OUT OF THE SYRINGE DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13546606 ↗
• MalfunctionNov 2, 2020Component Misassembled; Suction Failure; Component Misassembled; Suction Failure

  IT WAS REPORTED THAT THE SYRINGE HAD A LOOSE PLUNGER THAT FELL OUT OF THE SYRINGE.

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

  MAUDE report 10769896 ↗
• MalfunctionFeb 27, 2020Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A HAIR WAS FOUND INSIDE OF THE SYRINGE PRIOR TO USE.

  Patient problems: No Patient Involvement

  MAUDE report 9764188 ↗
• MalfunctionFeb 27, 2020Device Contamination with Chemical or Other Material; Device Contaminated During Manufacture or Shipping; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A HAIR WAS FOUND INSIDE OF THE SYRINGE PRIOR TO USE.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 9764185 ↗
• MalfunctionOct 30, 2019Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DIRT WAS FOUND INSIDE OF THE SYRINGE BEFORE USE.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 9257345 ↗
• MalfunctionAug 8, 2019Break; Break

  IT WAS REPORTED THAT THE TIP OF THE TOOMEY IRRIGATION SYRINGE DETACHED DURING USE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8875271 ↗
• MalfunctionMay 3, 2019Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS A HAIR INSIDE OF THE SYRINGE. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8579291 ↗
• MalfunctionSep 6, 2018Disconnection; Fluid/Blood Leak; Detachment of Device or Device Component; Disconnection

  IT WAS REPORTED THAT THE TIP OF THE PLUNGER CAME OFF AND THEREFORE THE SYRINGE LEAKED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7850136 ↗
• MalfunctionAug 9, 2018Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS A HAIR FOUND INSIDE THE SYRINGE UPON OPENING OF THE PACKET. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 7769826 ↗