N/A 302836Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00382903028368), received between Jun 25, 2019 and Aug 20, 2019 — classified as 2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A BROKEN PLUNGER WAS FOUND BEFORE USE WITH A SYRINGE 30ML ENTERAL S/C 56. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "I WOULD LIKE TO REPORT AN ISSUE THE NICU HAD OVER THE WEEKEND WITH THE 30ML ORAL/ENTERAL SYRINGE REF 302836. THEY HAD SEVERAL FROM THEIR SUPPLY IN WHICH THE PLASTIC ON THE PLUNGER WAS CRACKED."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8913381 ↗
• MalfunctionJun 25, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD¿ 30ML ENTERAL SYRINGE PLUNGER ROD WAS DAMAGED. THIS OCCURRED ON 3 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 302836 BATCH NO. 8360699. IT WAS REPORTED THAT THE PLUNGER ROD WAS DEFECTED/DAMAGED. PER EMAIL: NICU OPENED SYRINGE AND DISCOVERED 1.25 CRACK ON ONE FIN OF PLUNGER ABOUT 1' FROM END OF PLUNGER. SEVERAL OTHER SYRINGES WERE OPENED AND HAD SAME CRACK. THEY WERE ALL THE SAME LOT # 8360699. ALL PRODUCT WITH SAME LOT # WAS REMOVED FROM STOCK. PRODUCT CAME FROM CSC IN JAX; THEY WERE NOTIFIED OF LOT #.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8731543 ↗