Piston Syringe 0038470Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741049323), received between Sep 20, 2019 and Apr 3, 2020 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Suction Problem” (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.

• MalfunctionApr 3, 2020Suction Problem

  IT WAS REPORTED THAT THE SYRINGE DID NOT MAINTAIN SUCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9922661 ↗
• MalfunctionApr 2, 2020Suction Problem

  IT WAS REPORTED THAT THERE WAS NO SUCTION FOR TWO SYRINGES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9917896 ↗
• MalfunctionApr 2, 2020Suction Failure

  IT WAS REPORTED THAT THE SYRINGE DID NOT MAINTAIN SUCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9916936 ↗
• MalfunctionMar 4, 2020Fluid/Blood Leak

  IT WAS REPORTED THAT PISTON SYRINGES WERE NOT MAINTAINING THEIR SUCTION DURING USAGE, AND THE LIQUID WAS POURING BACK OUT. THE COMPLAINANT NOTED "YOU HAVE TO PUT YOUR THUMB IN THE RING AND KEEP THE TIP OF THE SYRINGE UPWARD AFTER THE SOLUTION HAS BEEN DRAWN IN ORDER THAT THE LIQUID COULD STAY IN THE SYRINGE. THAT¿S TOO MUCH MAINTENANCE." THE COMPLAINANT FURTHER WENT ON TO SAY THAT THE DEVICES WERE USED CORRECTLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9787963 ↗
• MalfunctionMar 4, 2020Decrease in Suction

  IT WAS REPORTED THAT THE PISTON SYRINGES WERE NOT MAINTAINING THEIR SUCTION DURING USAGE, AND THE LIQUID WAS POURING BACK OUT. THE COMPLAINANT NOTED "YOU HAVE TO PUT YOUR THUMB IN THE RING AND KEEP THE TIP OF THE SYRINGE UPWARD AFTER THE SOLUTION HAS BEEN DRAWN IN ORDER THAT THE LIQUID COULD STAY IN THE SYRINGE. THAT¿S TOO MUCH MAINTENANCE." THE COMPLAINANT FURTHER WENT ON TO SAY THAT THE DEVICES WERE USED CORRECTLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9787822 ↗
• MalfunctionSep 20, 2019Misassembled; Component Missing; Misassembled

  IT WAS REPORTED THAT THE CAP ON THE TIP WAS MISSING. PER ADDITIONAL INFORMATION RECEIVED FROM THE INVESTIGATOR ON 26SEP2019, THE CAP IS A REMOVABLE PIECE THAT IS PLACED IN THE SYRINGE TIP.

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

  MAUDE report 9100033 ↗