BD Preset™ Eclipse™ Arterial Blood Collection Syringe 364390Recalls & reported problems
Becton, Dickinson U.K. Limited · SYR ABG PRESET 3(1.6) LL 22X1 ECLIPSE CE · Class 2
All models of BD Preset Eclipse Arterial Blood Collection Syringe (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Preset Eclipse arterial blood collection syringe has 193 reports, 2 injuries and no deaths. Many reports describe samples leaking or splashing, and some describe foreign matter in the packaging or on the plunger. Reports fell from 84 in the prior 12 months to 29 in the most recent 12 months. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 192
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 192 adverse event reports that list this exact device (DI 50382903643900), received between Aug 28, 2018 and Sep 28, 2026 — classified as 2 injuries, 190 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (109 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/Splash109
- Device Contamination with Chemical or Other Material28
- Volume Accuracy Problem16
- Device Markings/Labelling Problem7
- Fluid/Blood Leak6
- Difficult or Delayed Activation4
- Detachment of Device or Device Component3
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions186
- No Known Impact Or Consequence To Patient4
- Needle Stick/Puncture2
Recent adverse event reports
The 25 most recent of 192 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915165 ↗MalfunctionSep 15, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50777684 ↗MalfunctionSep 8, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50676778 ↗MalfunctionMay 28, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD PRESET¿ ECLIPSE¿ ARTERIAL BLOOD COLLECTION SYRINGE, THE CAP HAD NOT BEEN SCREWED ON TIGHTLY ENOUGH RESULTING IN SAMPLE LEAKAGE. REPEAT COLLECTION OCCURRED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25319053 ↗MalfunctionMay 21, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED WHILE USING BD PRESET¿ ECLIPSE¿, A FOREIGN OBJECT WAS SEEN ON THE PLUNGER OF ONE DEVICE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25242683 ↗MalfunctionMay 18, 2026Difficult or Delayed Activation
IT WAS REPORTED WHILE USING BD PRESET¿ ECLIPSE¿ ARTERIAL BLOOD COLLECTION SYRINGE, THE LOCKING MECHANISM BECAME UNUSABLE ON ONE DEVICE AND TESTING HAD TO BE PERFORMED BY MANUALLY REMOVING THE SAFETY DEVICE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25210824 ↗MalfunctionMay 14, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED PRIOR TO USING BD PRESET¿ ECLIPSE¿ ARTERIAL BLOOD COLLECTION SYRINGE, FOREIGN MATTER WAS OBSERVED IN 8 DEVICE PACKAGES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25167070 ↗MalfunctionMay 4, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED WHILE USING BD PRESET¿ ECLIPSE¿ ARTERIAL BLOOD COLLECTION SYRINGE, A HAIR WAS DISCOVERED INSIDE THE NEEDLE HUB OF ONE DEVICE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25073819 ↗MalfunctionMay 1, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED WHILE USING BD PRESET¿ ECLIPSE¿ ARTERIAL BLOOD COLLECTION SYRINGE, FOREIGN MATTER WAS FOUND ON THE FLANGES OF ONE (1) DEVICE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25060123 ↗MalfunctionMay 1, 2026Short Fill
IT WAS REPORTED WHILE USING BD PRESET¿ ECLIPSE¿ ARTERIAL BLOOD COLLECTION SYRINGE, INSUFFICIENT BLOOD FLOW WAS SEEN WITH ONE DEVICE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25056172 ↗MalfunctionApr 16, 2026Contamination of Device Ingredient or Reagent
IT WAS REPORTED THAT BEFORE USING ONE (1) BD PRESET¿ ECLIPSE¿ ARTERIAL BLOOD COLLECTION SYRINGE, BLACK FOREIGN MATTER WAS OBSERVED INSIDE THE SYRINGE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24899338 ↗MalfunctionMar 26, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD PRESET¿ ECLIPSE¿ ARTERIAL BLOOD COLLECTION SYRINGE, LEAKAGE OF BLOOD FROM THE NEEDLE HUB CAP WAS OBSERVED WITH THREE DEVICES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24701843 ↗MalfunctionMar 25, 2026Detachment of Device or Device Component
IT WAS REPORTED WHILE USING BD PRESET¿ ECLIPSE¿ ARTERIAL BLOOD COLLECTION SYRINGE, THE NEEDLE AND HOLDER CONNECTION DEFORMED IN ONE (1) DEVICE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24689487 ↗MalfunctionFeb 23, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD PRESET¿ ECLIPSE¿ ARTERIAL BLOOD COLLECTION SYRINGE, BLOOD LEAKED FROM THE DEVICE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24418318 ↗MalfunctionFeb 11, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD PRESET¿ ECLIPSE¿ ARTERIAL BLOOD COLLECTION SYRINGE, LEAKAGE OCCURRED DURING BLOOD COLLECTION OF ONE PATIENT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24314343 ↗MalfunctionJan 14, 2026Crack
IT WAS REPORTED THAT WHEN USING ONE (1) BD PRESET¿ ECLIPSE¿, A CRACK WAS OBSERVED IN THE HUB, RESULTING IN BLOOD LEAKAGE, REQUIRING RECOLLECTION OF THE SAMPLE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24071616 ↗MalfunctionJan 13, 2026Leak/Splash
IT WAS REPORTED THAT AFTER USING ONE (1) BD PRESET¿ ECLIPSE¿, BLOOD LEAKED FROM THE SYRINGE, REQUIRING RECOLLECTION OF THE SAMPLE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24059202 ↗MalfunctionJan 12, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT BEFORE USING ONE (1) BD PRESET¿ ECLIPSE¿ ARTERIAL BLOOD COLLECTION SYRINGE, FOREIGN MATERIAL WAS OBSERVED IN THE SYRINGE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24037837 ↗MalfunctionDec 22, 2025Volume Accuracy Problem; Volume Accuracy Problem
IT WAS REPORTED THAT WHEN USING ONE (1) BD PRESET¿ ECLIPSE¿ ARTERIAL BLOOD COLLECTION SYRINGE, BLOOD COULD NOT BE DRAWN INTO THE UNIT PROPERLY. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23863043 ↗MalfunctionDec 18, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHEN USING ONE (1) BD PRESET¿ ECLIPSE¿ ARTERIAL BLOOD COLLECTION SYRINGE, 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 23843465 ↗MalfunctionDec 15, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT BEFORE USING ONE (1) BD PRESET¿ ECLIPSE¿ ARTERIAL BLOOD COLLECTION SYRINGE, BLACK FOREIGN MATTER WAS OBSERVED IN DEVICE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23811354 ↗MalfunctionDec 15, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT BEFORE USING ONE (1) BD PRESET¿ ECLIPSE¿ ARTERIAL BLOOD COLLECTION SYRINGE, THE SCALE MARKINGS ARE MISSING. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23808362 ↗MalfunctionDec 15, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHEN USING ONE (1) BD PRESET¿ ECLIPSE¿ ARTERIAL BLOOD COLLECTION SYRINGE, THE BARREL WAS FOUND TO BE CRACKED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23803300 ↗MalfunctionDec 8, 2025Leak/Splash; Component Missing; Leak/Splash; Component Missing
IT WAS REPORTED THAT WHEN USING THE BD PRESET¿ ECLIPSE¿, BLOOD LEAKAGE PAST THE STOPPER, CLOTTING, AND BLOOD LEAKAGE WHEN THE CAP IS REMOVED WAS OBSERVED ON AN UNSPECIFIED NUMBER OF UNITS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23744037 ↗MalfunctionNov 17, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT AFTER USING THE BD PRESET¿ ECLIPSE¿, 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 23572728 ↗
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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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