BD Preset™ Arterial Blood Collection Syringe 364416Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 50382903644167), received between Oct 5, 2023 and Nov 26, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED AFTER DRAWING A BLOOD SAMPLE WITH A BD PRESET¿ SYRINGE THE CAP WAS LOOSE CAUSING BLOOD TO LEAK. BLOOD GOT ON THE GLOVES OF THE LAB TECHNICIAN. THIS OCCURRED WITH AN UNSPECIFIED NUMBER OF SYRINGES. THERE WAS NO REPORT OF ADVERSE IMPACT TO PATIENTS OR USERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20786328 ↗
• MalfunctionFeb 7, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO USE OF BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE, FOREIGN MATTER WAS FOUND ON THE PLUNGER STOPPER IN THE SYRINGE. THE DEVICE WAS REPLACED. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18664102 ↗
• MalfunctionJan 31, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHEN USING THE BD PRESET¿, AIR BUBBLES WERE PRESENT IN ONE OF THE SYRINGES. NO PATIENT IMPACT OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18614850 ↗
• MalfunctionDec 11, 2023Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT WHILE USING BD PRESET¿ THERE WAS INSUFFICIENT BLOOD FLOW OF 10 DEVICES. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18300853 ↗
• MalfunctionOct 5, 2023Filling Problem; Filling Problem

  IT WAS REPORTED THAT THE BD PRESET¿ HAD NO BLOOD COMING IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AT HOSPITAL WHEN THEY TRIED TO GET A SAMPLE WITH OUR ABG PRESET 1 ML. THE BLOOD WAS NOT COMING INTO SYRINGE. KINDLY NOTE THAT THEY WERE USING BD PRESET & DISPO 26G NEEDLE TO COLLECT THE SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17877799 ↗