MEDLINE DYND20325Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10080196031863), received between Jul 5, 2023 and Mar 21, 2024 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2024Crack; Leak/Splash; Crack; Leak/Splash

  IT WAS REPORTED THAT THE TIP OF THE PISTON IRRIGATION SYRINGE WAS CRACKED AND THAT THE DEVICE LEAKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18954493 ↗
• MalfunctionMar 21, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE BLACK PIECE OF THE PISTON IRRIGATION SYRINGE PLUNGER WAS "DISINTEGRATING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18954483 ↗
• MalfunctionMar 21, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT AN END USER NOTED THE PLUNGER OF THE PISTON IRRIGATION SYRINGE WAS "TIGHT" AND "HARD TO DRAW IN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18954337 ↗
• MalfunctionFeb 26, 2024Display Difficult to Read; Leak/Splash; Display Difficult to Read; Leak/Splash

  IT WAS REPORTED THAT THE BULB IRRIGATION SYRINGE WAS LEAKING AND THAT THE MARKINGS WERE DIFFICULT TO READ.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18777200 ↗
• InjuryOct 10, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE FACILITY THE PISTON SYRINGE DOES NOT HOLD ENOUGH SUCTION TO REMOVE A CLOT FROM THE FOLEY CATHETER.

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

  MAUDE report 17905280 ↗
• InjuryJul 5, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE FACILITY ON (B)(6) 2023 "THE PISTON SYRINGE WAS BEING USED FOR IRRIGATION DURING A PROCEDURE IN WHICH THE PROTECTIVE TIP UNKNOWINGLY BECAME DISLODGED FROM THE SYRINGE WHEN IT WAS USED".

  Patient problems: Foreign Body In Patient

  MAUDE report 17259625 ↗