BD Preset™ Arterial Blood Collection Syringe 364316Recalls & reported problems
Becton, Dickinson U.K. Limited · SYR ABG PRESET 3(1.6) LL CE · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 50382903643160), received between Feb 1, 2024 and Sep 21, 2026 — classified as 15 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash4
- Device Contamination with Chemical or Other Material3
- Short Fill3
- Device Markings/Labelling Problem2
- Break1
- Fluid/Blood Leak1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions15
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846036 ↗MalfunctionMar 9, 2026Device Markings/Labelling Problem
IT WAS REPORTED PRIOR TO USING BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE, THE PACKAGING WAS MISSING THE LOT NUMBER. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24553340 ↗MalfunctionMar 3, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED PRIOR TO USING BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE, FOREIGN MATTER WAS FOUND IN THE STERILE PACKAGING OF 1 DEVICE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24503410 ↗MalfunctionMar 3, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED PRIOR TO USING BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE, FOREIGN MATTER WAS FOUND IN THE STERILE PACKAGING OF 1 DEVICE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24503161 ↗MalfunctionDec 18, 2025Short Fill; Short Fill
PATIENT 1 OF 3: IT WAS REPORTED WHEN USING BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE, THERE WAS INADEQUATE BLOOD VOLUME IN AN UNSPECIFIED NUMBER OF DEVICES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23838599 ↗MalfunctionDec 17, 2025Short Fill; Short Fill
PATIENT 3 OF 3: IT WAS REPORTED WHEN USING BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE, THERE WAS INADEQUATE BLOOD VOLUME IN AN UNSPECIFIED NUMBER OF DEVICES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23831321 ↗MalfunctionDec 17, 2025Short Fill; Short Fill
PATIENT 2 OF 3: IT WAS REPORTED WHEN USING BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE, THERE WAS INADEQUATE BLOOD VOLUME IN AN UNSPECIFIED NUMBER OF DEVICES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23831316 ↗MalfunctionNov 17, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT WHEN USING ONE (1) BD PRESET¿, THE PLUNGER STOPPER IS DEFORMED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23573653 ↗MalfunctionOct 27, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHEN USING ONE (1) BD PRESET¿, THE SYRINGE LEAKS BLOOD. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23391788 ↗MalfunctionOct 20, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHEN USING THE BD PRESET¿, BLOOD LEAKED PAST THE STOPPER OF TWO (2) UNITS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23341421 ↗MalfunctionJul 14, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT AFTER USING ONE (1) BD PRESET¿, BLOOD LEAKED PAST THE STOPPER. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22494192 ↗MalfunctionJun 9, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT BEFORE USING ONE (1) BD PRESET¿, DEBRIS WAS FOUND INSIDE THE SYRINGE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22168188 ↗MalfunctionFeb 19, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT BEFORE USING THE BD PRESET¿, ONE CASE EXHIBITED MISSING PRODUCT LABELS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21411488 ↗MalfunctionOct 22, 2024Break; Break
IT WAS REPORTED WHILE USING A BD PRESET¿ SYRINGE, THE BARREL OF THE SYRINGE WAS CRACKED. THERE WAS NO REPORT OF ADVERSE IMPACT TO PATIENTS OR USERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20507315 ↗MalfunctionFeb 1, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHILE USING BD PRESET¿, BLOOD LEAKED INTO THE OUTER SLEEVE. NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18624550 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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