MEDLINE DYND20302Recalls & reported problems
Medline Industries, Inc. · TRAY,IRRIGATION,PISTON SYRINGE,60ML,STRL · Class 1
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10080196031801), received between May 26, 2023 and Aug 18, 2025 — classified as 1 injury, 14 malfunctions.
The most frequently reported specific device problem is “Suction Problem” (4 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.
Reports received per month
Most reported problems
Device problems
- Suction Problem4
- Detachment of Device or Device Component3
- Appropriate Device Problem Term/Code Not Available2
- Leak/Splash2
- Material Separation2
- Break1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- Exposure to Body Fluids1
- Insufficient Information1
- Pain1
- Unspecified Kidney or Urinary Problem1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 18, 2025Material Separation; Material Separation
IT WAS REPORTED THAT ON (B)(6) 2025 THE SYRINGE WAS BEING USED TO IRRIGATE A PATIENT'S CBI CATHETER AND THE "RUBBER COMPONENT IN THE SYRINGE BECAME DISLODGED" CAUSING THE CLINICIAN'S "EYES" TO GET "SPLASHED WITH BODILY FLUIDS / BLOOD CONTAINING FLUIDS".
Patient problems: Exposure to Body Fluids
MAUDE report 22835531 ↗MalfunctionOct 29, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE FACILITY ON 10/2, "PATIENT PRESENTED WITH GROSS HEMATURIA REQUIRING BLADDER IRRIGATION. IRRIGATION SYRINGES WERE NOT ABLE TO HOLD SUCTION AND COMPLETELY MALFUNCTION."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20561732 ↗MalfunctionMay 21, 2024Material Integrity Problem; Material Integrity Problem
MalfunctionMay 21, 2024Break; Break
IT WAS REPORTED THAT ON (B)(6) 2024 WHEN ATTEMPTING TO IRRIGATE CLOTS FROM A PATIENT ON A "CBI" THAT HAD CLOTTED OFF THE "PISTON SYRINGE BROKE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19365581 ↗MalfunctionMay 21, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE FACILITY ON (B)(6) 2024 "PATIENT ON CBI AND CLOTTED OFF, NEEDED TO BE MANUALLY IRRIGATED IN EFFORTS TO REMOVE THE CLOTS, PISTON SYRINGE BROKE, AND NURSE HAD TO RUN TO ANOTHER UNIT TO GRAB ANOTHER SET".
Patient problems: Pain
MAUDE report 19360215 ↗MalfunctionMar 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PISTON IRRIGATION SYRINGE PLUNGER AND STOPPER DISLODGED WHEN THE PLUNGER WAS PULLED BACK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18955745 ↗MalfunctionMar 21, 2024Suction Problem; Suction Problem
IT WAS REPORTED THAT THE PISTON IRRIGATION SYRINGE HAD LOW SUCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18955403 ↗MalfunctionMar 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PISTON IRRIGATION SYRINGE HAD MULTIPLE PROBLEMS/ISSUES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18955116 ↗MalfunctionMar 21, 2024Suction Problem; Suction Problem
IT WAS REPORTED THAT THE PISTON IRRIGATION SYRINGE EXPERIENCED MULTIPLE PROBLEMS/ISSUES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18954560 ↗MalfunctionMar 21, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE PISTON IRRIGATION SYRINGE "SPRAYED" WHEN IT WAS INSERTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18954156 ↗MalfunctionMar 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE BLACK RUBBER PIECE OF THE SYRINGE PLUNGER DETACHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18953834 ↗MalfunctionMar 4, 2024Suction Problem; Suction Problem
IT WAS REPORTED THAT THE PISTON IRRIGATION SYRINGE DOES NOT HOLD SUCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18825626 ↗MalfunctionMar 4, 2024Material Separation; Material Separation
IT WAS REPORTED THAT THE PISTON IRRIGATION SYRINGE SEPARATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18825618 ↗MalfunctionFeb 26, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BULB IRRIGATION SYRINGE WAS LEAKING AND THE PLUNGER WAS "WOBBLY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18777191 ↗InjuryMay 26, 2023Suction Problem; Suction Problem
SYRINGE DID NOT PROVIDE ENOUGH SUCTION.
Patient problems: Unspecified Kidney or Urinary Problem
MAUDE report 17011153 ↗
Other SYRINGE, IRRIGATING (NON DENTAL) devices
- Irrigation Syringe 0935280C. R. Bard, Inc. · SYRINGE, IRRIGATING (NON DENTAL)83 reports
- N/A 309620Becton, Dickinson And Company · SYRINGE, IRRIGATING (NON DENTAL)73 reports
- Irrigation Syringe 0035280C. R. Bard, Inc. · SYRINGE, IRRIGATING (NON DENTAL)58 reports
- MEDLINE DYND20125Medline Industries, Inc. · SYRINGE, IRRIGATING (NON DENTAL)1 recall3 reports
- NICO Fluid System NN-8015Nico Corporation · Syringe, Irrigating (Non Dental)1 recall0 reports
- Rapid Refill M00566000Boston Scientific Corporation · SYRINGE, IRRIGATING (NON DENTAL)1 recall0 reports
- Piston Irrigation Tray 750307C. R. Bard, Inc. · SYRINGE, IRRIGATING (NON DENTAL)15 reports
- Toomey Syringe 0038460C. R. Bard, Inc. · SYRINGE, IRRIGATING (NON DENTAL)9 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.