BD Luer-Lok, BD Eclipse 305785Recalls & reported problems
Becton, Dickinson And Company · Syringe 5ml LL w/Needle 22x1-1/2in RB · Class 2
All models of BD Luer-Lok, BD Eclipse (12)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00382903057856), received between Feb 27, 2019 and Jan 26, 2023 — classified as 1 injury, 13 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (5 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 16, 2026.
Most reported problems
Device problems
- Leak/Splash5
- Break4
- Defective Component2
- Material Protrusion/Extrusion2
- Fail-Safe Did Not Operate1
- Fail-Safe Problem1
- Failure to Deliver1
- Volume Accuracy Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- No Known Impact Or Consequence To Patient4
- No Patient Involvement2
- Needle Stick/Puncture1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 26, 2023Break; Break
IT WAS REPORTED WHILE USING BD LUER-LOK¿ SYRINGE WITH BD ECLIPSE¿ SAFETY THE DEVICE WAS DAMAGED.THERE WAS NO REPORT OF PATIENT IMPACT.THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BROKEN BARREL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16250996 ↗MalfunctionJun 15, 2022Defective Component; Defective Component
IT WAS REPORTED BY THE CUSTOMER THAT THE BD ECLIPSE¿ 5ML LUER-LOCK SYRINGE W DETACHABLE NEEDLE PLUNGER WAS LOOSE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PLUNGER IS LOOSE AND INCIDENT OCCURED DURING USE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14702813 ↗MalfunctionMar 29, 2022Fail-Safe Problem; Fail-Safe Problem
IT WAS REPORTED THAT BD SYRINGE WITH HYPODERMIC NEEDLE ECLIPSE¿ HAD THE SAFETY MECHANISM DETACH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PINK SHIELD DISCONNECT".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13934935 ↗MalfunctionJan 24, 2022Break; Break
IT WAS REPORTED THAT THE PLUNGER IN THE BD LUER-LOK¿ SYRINGE WITH BD ECLIPSE¿ DETACHABLE NEEDLE WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BROKEN PLUNGER"
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13334037 ↗MalfunctionNov 15, 2021Defective Component; Defective Component
IT WAS REPORTED THAT THE BD 5ML LL SYRINGE EXPERIENCED STOPPER SEPARATION FROM THE PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISTORTED STOPPER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12815328 ↗MalfunctionMar 7, 2021Break; Leak/Splash; Break; Leak/Splash
IT WAS REPORTED THAT SYRINGE 5ML LL W/NEEDLE 22X1-1/2IN RB BARREL WAS DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISTORTED BARREL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11426839 ↗MalfunctionNov 18, 2020Leak/Splash; Failure to Deliver; Leak/Splash; Failure to Deliver
IT WAS REPORTED THAT SYRINGE 5ML LL W/NEEDLE 22X1-1/2IN RB PLUNGER WAS DIFFICULT TO MOVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LAST SEPTEMBER WE RECEIVED HUGE QUANTITY OF THE ABOVE MENTIONED ITEMS. HOWEVER I HAVE RECEIVED POOR QUALITY REVIEWS FROM MY STAFFS WHO ARE UTILIZING THESE ITEMS IN OUR BLOOD EXTRACTIONS AREAS. THESE ARE THEIR COMMON COMMENTS ABOUT THE PRODUCT: NO BACK-FLOW CAN BE SEEN IN THE HUB AREA OF THE SYRINGE IN ALL EXTRACTIONS DONE. THE MAXIMUM AMOUNT OF BLOOD CANNOT BE EXTRACTED FROM PATIENTS AT THE EXPECTED FULL CAPACITY OF THE SYRINGE. THE ITEMS (MOSTLY 5 CC AND 10 CC) REQUIRE AN EXTRA EFFORT IN PULLING THE PLUNGER DURING BLOOD EXTRACTION UNLIKE OTHER SIMILAR PRODUCTS THAT WE HAVE TRIED BEFORE WHICH CAN BE EASILY PULLED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10864671 ↗MalfunctionAug 17, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE STOPPER IN THE BD LUER-LOK¿ SYRINGE WITH BD ECLIPSE¿ DETACHABLE NEEDLE WAS FOUND DISTORTED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "STOPPER DISTORTED."
Patient problems: No Patient Involvement
MAUDE report 10418294 ↗MalfunctionJun 18, 2020Break; Leak/Splash; Break; Leak/Splash
IT WAS REPORTED THAT SYRINGE 5ML LL W/NEEDLE 22X1-1/2IN RB BARREL WAS DAMAGED. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EMPTY NEEDLE BARREL WITH BROKEN LACERATION.
Patient problems: No Patient Involvement
MAUDE report 10171336 ↗MalfunctionDec 10, 2019Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED THAT BD ECLIPSE¿ 5 ML BD LUER-LOK¿ SYRINGE CAP WAS LOOSE. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PINK CAP LOOSE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9444180 ↗MalfunctionAug 30, 2019Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED THAT THE SYRINGE 5ML LL W/NEEDLE 22X1-1/2IN RB EXPERIENCED DIFFICULTY ENGAGING THE SAFETY MECHANISM DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHITE CAP IS LOOSE. WHEN THE PINK COVER IS SQUATTING, THE WHITE CAP IS DIRECTLY RELEASED, AND THE CAREGIVER ALMOST PINCHES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8951688 ↗MalfunctionAug 27, 2019Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ECLIPSE¿ 5-ML BD LUER-LOK SYRINGE W/ DETACHABLE NEEDLE STOPPER WAS DEFORMED. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISTORTED STOPPER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8935416 ↗MalfunctionAug 27, 2019Volume Accuracy Problem; Volume Accuracy Problem
IT WAS REPORTED THAT BD ECLIPSE¿ 5-ML BD LUER-LOK SYRINGE W/ DETACHABLE NEEDLE HAS MISSING SCALE MARKINGS. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SCALE MISSING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8935308 ↗InjuryFeb 27, 2019Fail-Safe Did Not Operate
IT WAS REPORTED THAT BD SYRINGE¿ 5ML LL W/NEEDLE 22X1-1/2IN RB SAFETY SHIELD DID NOT COMPLETELY COVER NEEDLE WHICH RESULTED IN THE NURSE BEING STUCK BY THE NEEDLE.
Patient problems: Needle Stick/Puncture
MAUDE report 8373932 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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