BD Preset™ Eclipse™ Arterial Blood Collection Syringe 364391Recalls & reported problems
Becton, Dickinson U.K. Limited · SYR ABG PRESET 3(1.6) LL 23X1 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 arterial blood samples for testing. The 48 reports mostly describe blood leaking or splashing out of the syringe, along with some volume accuracy issues, blood clotting inside the device, and foreign material found on the needle or inside the barrel before use. None of the reports describe a death or an injury. There are no recalls naming this device. Reports in the last 12 months fell from 15 to 6.
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
- 47
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 50382903643917), received between Oct 30, 2023 and May 21, 2026 — classified as 47 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (21 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/Splash21
- Device Contamination with Chemical or Other Material6
- Volume Accuracy Problem6
- Coagulation in Device or Device Ingredient4
- Device Markings/Labelling Problem3
- Device Ingredient or Reagent Problem2
- Component Missing1
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions47
Recent adverse event reports
The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 21, 2026Fluid/Blood Leak
IT WAS REPORTED WHILE USING BD PRESET¿ ECLIPSE¿ ARTERIAL BLOOD COLLECTION SYRINGE, BLOOD LEAKED PAST THE PLUNGER OF FIVE (5) DEVICES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25247326 ↗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 MATTER WAS PRESENT ON THE NEEDLE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24037531 ↗MalfunctionJan 2, 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 BARREL. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23948278 ↗MalfunctionNov 17, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHEN USING THE BD PRESET¿ ECLIPSE¿, BLOOD LEAKS PAST THE STOPPER. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23570560 ↗MalfunctionNov 17, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT AFTER USING ONE (1) BD PRESET¿ ECLIPSE¿, 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 23570104 ↗MalfunctionOct 16, 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 ON THE STOPPER OF THE SYRINGE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23311266 ↗MalfunctionSep 16, 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 FOUND ON THE CANNULA TIP. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23063022 ↗MalfunctionAug 28, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT AFTER USING ONE (1) BD PRESET¿ ECLIPSE¿, THE CAP WAS LOOSE AFTER COLLECTING THE SAMPLE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22912694 ↗MalfunctionAug 28, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT AFTER USING THE BD PRESET¿ ECLIPSE¿, THE CAPS WERE OBSERVED TO BE LOOSE ON SIX (6) UNITS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22912677 ↗MalfunctionAug 28, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT AFTER USING THE BD PRESET¿ ECLIPSE¿, THE CAPS DO NOT CLOSE PROPERLY ON TWO (2) UNITS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22912675 ↗MalfunctionAug 28, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT AFTER USING THE BD PRESET¿ ECLIPSE¿, THE CAP DOES NOT CLOSE PROPERLY ON TWO (2) UNITS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22912669 ↗MalfunctionJul 10, 2025Volume Accuracy Problem; Volume Accuracy Problem
IT WAS REPORTED THAT WHEN USING THE BD PRESET¿ ECLIPSE¿, AN UNSPECIFIED NUMBER OF UNITS EXPERIENCED LIMITED FLOW INTO THE DEVICE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22470795 ↗MalfunctionJul 10, 2025Volume Accuracy Problem; Volume Accuracy Problem
IT WAS REPORTED THAT WHEN USING THE BD PRESET¿ ECLIPSE¿, AN UNSPECIFIED NUMBER OF UNITS EXPERIENCED LIMITED FLOW INTO THE DEVICE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22469483 ↗MalfunctionJun 30, 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¿, A BROWN SUBSTANCE WAS ATTACHED TO THE PRODUCT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22363247 ↗MalfunctionJun 5, 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 MATTER WAS OBSERVED ON THE PLUNGER STOPPER. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22153591 ↗MalfunctionApr 17, 2025Product Quality Problem; Product Quality Problem
IT WAS REPORTED THAT BEFORE USING ONE (1) BD PRESET¿ ECLIPSE¿, THE WHITE NON-PATIENT SHIELD WAS MISSING FROM THE NEEDLE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21861004 ↗MalfunctionJan 8, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED AFTER USING BD PRESET¿ ECLIPSE¿, BLOOD LEAKED FROM THE DEVICE. THIS OCCURRED THREE (3) TIMES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21104141 ↗MalfunctionNov 27, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED WHILE USING A BD PRESET¿ ECLIPSE¿ SYRINGE BLOOD LEAKED PAST THE PLUNGER STOPPER. THIS OCCURRED WITH THREE (3) DEVICES. THERE WAS NO REPORT OF ADVERSE IMPACT TO PATIENTS OR USERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20795888 ↗MalfunctionNov 25, 2024Volume Accuracy Problem; Volume Accuracy Problem
IT WAS REPORTED WHILE USING BD PRESET¿ ECLIPSE¿ SYRINGES THE BLOOD FLOW WAS INSUFFICIENT TO FILL THE SYRINGE. THIS REQUIRED BLOOD SAMPLES TO BE RE-DRAWN. THIS OCCURRED WITH AN UNSPECIFIED NUMBER OF DEVICES. THERE WAS NO REPORT OF ADVERSE IMPACT TO PATIENTS OR USERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20770689 ↗MalfunctionNov 12, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED WHILE USING A BD PRESET¿ ECLIPSE¿ SYRINGE BLOOD LEAKED PAST THE PLUNGER STOPPER. THIS OCCURRED WITH 100 SYRINGES. THERE WAS NO REPORT OF ADVERSE IMPACT TO PATIENTS OR USERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20663195 ↗MalfunctionOct 28, 2024Component Missing; Component Missing
IT WAS REPORTED AFTER USING A BD PRESET¿ ECLIPSE¿ SYRINGE, IT WAS NOTICED THE SAFETY SHIELD WAS MISSING. THERE WAS NO REPORT OF ADVERSE IMPACT TO PATIENTS OR USERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20545888 ↗MalfunctionOct 10, 2024Missing Information; Missing Information
IT WAS REPORTED A CASE OF BD PRESET¿ ECLIPSE¿ SYRINGES WAS MISSING ITS CASE LABEL. THERE WAS NO REPORT OF ADVERSE IMPACT TO PATIENTS OR USERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20422462 ↗MalfunctionOct 9, 2024Volume Accuracy Problem; Volume Accuracy Problem
IT WAS REPORTED WHEN USING THE BD PRESET¿ ECLIPSE¿ ARTERIAL BLOOD COLLECTION SYRINGE, THE NEEDLES ARE BLUNT AND SHORT, AS WELL AS INSUFFICIENT BLOOD FLOW IN AN UNSPECIFIED NUMBER OF SYRINGES. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20412123 ↗MalfunctionOct 8, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED WHILE USING A BD PRESET¿ ECLIPSE¿ SYRINGE, BLOOD LEAKED PAST THE PLUNGER STOPPER. THERE WAS NO REPORT OF ADVERSE IMPACT TO PATIENTS OR USERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20400038 ↗MalfunctionOct 4, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED WHILE USING A BD PRESET¿ ECLIPSE¿ SYRINGE, BLOOD LEAKED PAST THE PLUNGER STOPPER. A NEW BLOOD SAMPLE WAS COLLECTED FROM THE PATIENT. THIS OCCURRED WITH THREE (3) DEVICES. THERE WAS NO REPORT OF ADVERSE IMPACT TO PATIENTS OR USERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20371443 ↗
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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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