Piston Irrigation Tray 750307Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00801741051111), received between Apr 23, 2019 and Jun 15, 2020 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 15, 2020Fluid/Blood Leak

  IT WAS REPORTED THAT NORMAL SALINE BEGAN TO LEAK FROM THE PISTON SYRINGE DURING USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10155425 ↗
• MalfunctionMay 27, 2020Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED THAT THE PRODUCT BOX WAS LABELED 750307 BUT WHEN OPENED IT CONTAINED A PRODUCT WITH LABEL 555525/CESK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10090642 ↗
• MalfunctionApr 2, 2020Inability to Irrigate

  IT WAS REPORTED THAT THE IRRIGATION SYRINGES WERE NOT HOLDING A SEAL, SO WHEN TRYING TO DRAW UP VOLUME TO IRRIGATE, IRRIGATION FLUID JUST POURED BACK OUT. HEALTH PROFESSIONALS WERE NOT ABLE TO FILL THE SYRINGE, WHICH WAS NECESSARY TO EFFECTIVELY IRRIGATE A BLADDER. FOUR DIFFERENT IRRIGATION SYRINGES WERE TRIED, ALL WITH THE SAME RESULT AND ALL WITH THE SAME LOT NUMBER. PER COMPLAINANT STATEMENT, IT SIGNIFICANTLY AFFECTED PATIENT CARE OVER APPROXIMATELY 20 HOURS. NIGHT SHIFT WAS UNABLE TO PROPERLY IRRIGATE THE CLOTS, WHICH REQUIRED A FOLEY CATHETER REPLACEMENT. THE PATIENT WAS SCHEDULED FOR SURGERY THE NEXT MORNING. AFTER SURGERY, DAY SHIFT WAS UNABLE TO PROPERLY IRRIGATE THE FOLEY WHEN IT BECAME CLOTTED AGAIN, SO IT WAS AGAIN EXCHANGED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9916488 ↗
• MalfunctionMar 27, 2020Break

  IT WAS REPORTED THAT WHEN PULLING BACK THE SYRINGE TO PULL UP FLUID, AFTER ABOUT 20 OR 30 MLS, THE VACUUM SEAL BROKE AND ALL OF THE FLUID FELL OUT OF THE DEVICE. NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9889920 ↗
• MalfunctionMar 27, 2020Suction Failure

  IT WAS REPORTED THAT THE SYRINGES DID NOT RETAIN LIQUID, AND THERE WAS NO SUCTION. PER PHONE CALL ON (B)(6) 2020, HEALTH PROFESSIONAL CALLED TO REPORT THE SYRINGES IN THE IRRIGATION TRAY WOULD NOT RETAIN WHAT THEY DRAW UP AS IF THERE WAS NO SUCTION. THEY FOUND 3-4 THAT WOULD NOT WORK LIKE. HOWEVER, THEY WERE ABLE TO USE OTHER LOTS, AND THERE WAS NO HARM OR CHANGE TO TREATMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9888226 ↗
• MalfunctionMar 19, 2020Fluid/Blood Leak

  IT WAS REPORTED THAT THEY HAD 8 SYRINGES WITH LEAKING ISSUES. ONE OF THE SYRINGES WAS USED, AND 7 WERE NOT USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9853542 ↗
• MalfunctionMar 19, 2020Leak/Splash

  IT WAS REPORTED THAT THEY HAD 8 SYRINGES WITH LEAKING ISSUES. ONE OF THE SYRINGES WAS USED, AND 7 WERE NOT USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9853233 ↗
• MalfunctionMar 17, 2020Decrease in Suction

  IT WAS REPORTED THAT THE SYRINGE WAS NOT HOLDING SUCTION, AND SO THE WATER DRIPPED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9844631 ↗
• MalfunctionMar 17, 2020Fluid/Blood Leak

  IT WAS REPORTED THAT THE SYRINGE WAS NOT HOLDING SUCTION, AND THE WATER DRIPPED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9844625 ↗
• MalfunctionMar 17, 2020Decrease in Suction; Fluid/Blood Leak

  IT WAS REPORTED THAT THE SYRINGE WAS NOT HOLDING SUCTION, AND THE WATER DRIPPED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9844529 ↗
• MalfunctionMar 17, 2020Suction Failure

  IT WAS REPORTED THAT THE SYRINGE WAS NOT HOLDING SUCTION, AND THE WATER DRIPPED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9844492 ↗
• MalfunctionMar 17, 2020Fluid/Blood Leak

  IT WAS REPORTED THAT THE SYRINGE WAS NOT HOLDING SUCTION, AND SO THE WATER DRIPPED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9844483 ↗
• MalfunctionMar 9, 2020Fluid/Blood Leak; Suction Problem

  IT WAS REPORTED THAT THE PISTON SYRINGE DOES NOT HOLD ANY SUCTION SO IT DOES NOT HOLD THE FLUID, RESULTING IN THE PATIENT AND BED GETTING WET.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9805690 ↗
• MalfunctionMar 6, 2020Leak/Splash

  IT WAS REPORTED THAT THE SYRINGE LEAKED, AND THEREFORE WOULD NOT HOLD THE FLUID.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9800587 ↗
• MalfunctionApr 23, 2019Break; Leak/Splash; Material Puncture/Hole; Break

  IT WAS REPORTED THAT THERE WAS A HOLE IN THE BOTTOM OF THE SYRINGE THAT RESULTED IN A LEAK. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 8540764 ↗