BD Preset™ Eclipse™ Arterial Blood Collection Syringe 364389Recalls & reported problems
Becton, Dickinson U.K. Limited · SYR ABG PRESET 3(1.6) 22X1.25 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 is used to draw blood samples from an artery. The 39 reports mostly describe packaging and labeling issues, syringes arriving with foreign material inside the plunger, blood leaking out, missing or blurred volume markings, and parts missing from the package. One injury was reported, a needle stick, and no deaths. There are no recalls naming 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
- 39
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 50382903643894), received between Nov 22, 2023 and Sep 16, 2026 — classified as 1 injury, 38 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (8 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
- Device Contamination with Chemical or Other Material8
- Packaging Problem8
- Leak/Splash6
- Component Missing5
- Volume Accuracy Problem4
- Detachment of Device or Device Component2
- Device Markings/Labelling Problem2
- Product Quality Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions38
- Needle Stick/Puncture1
Recent adverse event reports
The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50793757 ↗MalfunctionMay 21, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED PRIOR TO USING BD PRESET¿ ECLIPSE¿ ARTERIAL BLOOD COLLECTION SYRINGE, ONE DEVICE CONTAINED FOREIGN MATTER ON THE PLUNGER. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25242251 ↗MalfunctionMay 15, 2026Missing Information
IT WAS REPORTED THAT BEFORE USAGE BD PRESET¿ ECLIPSE¿ ARTERIAL BLOOD COLLECTION SYRINGE, VOLUMETRIC MARKING WAS MISSING ON 1 DEVICE. NO ADVERSE IMPACT WAS REPORTED REGARDING PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25191205 ↗MalfunctionMay 4, 2026Device Markings/Labelling Problem
IT WAS REPORTED THAT PRIOR TO USING BD PRESET¿ ECLIPSE¿ ARTERIAL BLOOD COLLECTION SYRINGE, ONE SYRINGE WAS MISSING THE SCALE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25073375 ↗MalfunctionApr 22, 2026Device Markings/Labelling Problem
IT WAS REPORTED THAT AFTER USING BD PRESET¿ ECLIPSE¿ ARTERIAL BLOOD COLLECTION SYRINGE, THE SCALE PRINTING ON ONE DEVICE WAS BLURRED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24958329 ↗MalfunctionNov 3, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHEN USING THE BD PRESET¿ ECLIPSE¿, AN UNSPECIFIED NUMBER OF UNITS EXHIBITED BLOOD LEAKAGE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23452406 ↗MalfunctionOct 20, 2025Volume Accuracy Problem; Volume Accuracy Problem
IT WAS REPORTED THAT BEFORE USING ONE (1) BD PRESET¿ ECLIPSE¿, NO SCALE WAS PRINTED ON THE BARREL OF THE SYRINGE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23336858 ↗MalfunctionOct 15, 2025Product Quality Problem; Product Quality Problem
IT WAS REPORTED THAT BEFORE USING ONE (1) BD PRESET¿ ECLIPSE¿, THE PACKAGING OF THE SYRINGE AND THE CAP OF THE SYRINGE WERE DISFIGURED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23303410 ↗MalfunctionSep 16, 2025Difficult or Delayed Activation; Difficult or Delayed Activation
IT WAS REPORTED THAT BEFORE USING ONE (1) BD PRESET¿ ECLIPSE¿, THE SAFETY MECHANISM BROKE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23062994 ↗MalfunctionJun 18, 2025Volume Accuracy Problem; Volume Accuracy Problem
IT WAS REPORTED THAT WHEN USING ONE (1) BD PRESET¿ ECLIPSE¿, THERE WAS NO BLOOD FLOW INTO THE SYRINGE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22284663 ↗MalfunctionMay 1, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHEN USING ONE (1) BD PRESET¿ ECLIPSE¿, THE BARREL OF THE SYRINGE IS CRACKED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21942925 ↗MalfunctionApr 25, 2025Volume Accuracy Problem; Volume Accuracy Problem
IT WAS REPORTED THAT WHEN USING THE BD PRESET¿ ECLIPSE¿, THERE IS NO BLOOD FLOW ON THREE (3) UNITS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21913678 ↗MalfunctionMar 7, 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¿, FOREIGN MATERIAL 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 21548554 ↗MalfunctionFeb 25, 2025Component Missing; Component Missing
IT WAS REPORTED THAT BEFORE USING TWO (2) BD PRESET¿ ECLIPSE¿ DEVICES, THERE WAS 1 CLEAN NEEDLE STICK, BUT 2 DEVICES WERE MISSING THE SAFETY SHIELD. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21460601 ↗MalfunctionFeb 7, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT WHEN USING THE BD PRESET¿ ECLIPSE¿, WATER DROPLETS WERE OBSERVED INSIDE THE SYRINGE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21333943 ↗MalfunctionJan 31, 2025Packaging Problem; Packaging Problem
IT WAS REPORTED THAT WHEN USING BD PRESET¿ ECLIPSE¿, THE UNIT PACKAGING WAS OBSERVED TO BE TORN OPEN BEFORE THE PRODUCT WAS USED ON THE PATIENT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21282688 ↗MalfunctionJan 21, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED WHILE USING BD PRESET¿ ECLIPSE¿, 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 21198397 ↗MalfunctionJan 8, 2025Packaging Problem; Packaging Problem
IT WAS REPORTED PRIOR TO USING BD PRESET¿ ECLIPSE¿, THE BAG WAS TORN, COMPROMISING DEVICE STERILITY. THE CAP WAS ALSO DAMAGED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21104135 ↗MalfunctionJan 2, 2025Packaging Problem; Packaging Problem
IT WAS REPORTED PRIOR TO USING BD PRESET¿ ECLIPSE¿ THE PACKAGING WAS DAMAGED, COMPROMISING DEVICE STERILITY. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21057599 ↗MalfunctionDec 4, 2024Packaging Problem; Packaging Problem
IT WAS REPORTED PRIOR TO USING A BD PRESET¿ ECLIPSE¿ SYRINGE THE SYRINGE WAS FOUND IN ITS UNIT PACKAGING WITHOUT AN IV SHIELD. THERE WAS NO REPORT OF ADVERSE IMPACT TO PATIENTS OR USERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20844169 ↗MalfunctionNov 25, 2024Component Missing; Component Missing
IT WAS REPORTED PRIOR TO USING A BD PRESET¿ ECLIPSE¿ SYRINGE THERE WAS NO IV SHIELD ON THE DEVICE, LEAVING THE NEEDLE EXPOSED. THERE WAS NO REPORT OF ADVERSE IMPACT TO PATIENTS OR USERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20773240 ↗MalfunctionSep 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED PRIOR TO USING A BD PRESET¿ ECLIPSE¿ SYRINGE, THE IV SHIELD HAD FALLEN OFF. THERE WAS NO REPORT OF ADVERSE IMPACT TO PATIENTS OR USERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20163232 ↗MalfunctionSep 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED PRIOR TO USING A BD PRESET¿ ECLIPSE¿ SYRINGE, THE IV SHIELD HAD FALLEN OFF. THERE WAS NO REPORT OF ADVERSE IMPACT TO PATIENTS OR USERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20148050 ↗MalfunctionAug 28, 2024Component Missing; Component Missing
IT WAS REPORTED PRIOR TO USING A BD PRESET¿ ECLIPSE¿ SYRINGE, THE SYRINGE DID NOT HAVE AN IV SHIELD WHICH LEFT THE CANNULA EXPOSED IN THE UNIT PACKAGING. NO ADVERSE IMPACT TO PATIENTS OR USERS WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20091589 ↗MalfunctionAug 13, 2024Component Missing; Component Missing
IT WAS REPORTED PRIOR TO USING A BD PRESET¿ ECLIPSE¿ SYRINGE, THE SYRINGE WAS MISSING ITS IV SHIELD RESULTING IN A CLEAN NEEDLE STICK INJURY TO THE USER. AN ADDITIONAL SYRINGE WAS FOUND WITHOUT AN IV SHIELD IN THE SAME SHELF CARTON. NO FURTHER IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19973176 ↗
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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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