BD Luer-Lok, BD Eclipse 305786Recalls & reported problems
Becton, Dickinson And Company · SYR 10ML LL W/NDL ECLIPSE 22X1-1/2 RB · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00382903057863), received between Dec 15, 2017 and Mar 13, 2024 — classified as 1 injury, 15 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (6 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash6
- Device Contamination with Chemical or Other Material3
- Contamination /Decontamination Problem2
- Break1
- Detachment of Device or Device Component1
- Failure to Deliver1
- Material Discolored1
- Packaging Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- No Known Impact Or Consequence To Patient6
- No Consequences Or Impact To Patient3
- No Patient Involvement2
- Eye Injury1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 13, 2024Packaging Problem; Packaging Problem
THE PACKAGING WAS NOT DEVELOPED AND THE SYRINGE WAS DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18895938 ↗MalfunctionJun 2, 2023Break; Break
IT WAS REPORTED THAT THE BD LUER-LOK SYRINGE WITH BD ECLIPSE SAFETY NEEDLE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE IS A BREAKAGE IN THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17050349 ↗MalfunctionMar 29, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT SYR 10ML LL W/NDL ECLIPSE 22X1-1/2 RB STOPPER DISCONNECTED FROM THE PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISCONNECT BETWEEN STOPPER AND PLUNGER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11586623 ↗MalfunctionMar 29, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE SYR 10ML LL W/NDL ECLIPSE 22X1-1/2 RB LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SYRINGE LEAK."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11585862 ↗MalfunctionDec 29, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE SYR 10ML LL W/NDL ECLIPSE 22X1-1/2 RB EXPERIENCED A PLUNGER ROD THAT WAS INCORRECTLY POSITIONED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN END-USER OPEN PACKAGE FOR USE, FOUND THE BD ECLIPSE NEEDLE ANGLED / TILTED / BENT - NOT STRAIGHT. AND THE SYRINGES PLUNGER RUBBER IS DEFECTED / DAMAGED / IMPROPERLY FIXED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11092586 ↗MalfunctionDec 29, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT SYR 10ML LL W/NDL ECLIPSE 22X1-1/2 RB WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN END-USER OPEN PACKAGE FOR USE, FOUND THE BD ECLIPSE NEEDLE ANGLED / TILTED / BENT - NOT STRAIGHT. AND THE SYRINGES PLUNGER RUBBER IS DEFECTED / DAMAGED / IMPROPERLY FIXED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 11089878 ↗MalfunctionDec 16, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THE SYR 10ML LL W/NDL ECLIPSE 22X1-1/2 RB EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DIRTY INSIDE THE EMPTY NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11017416 ↗MalfunctionNov 18, 2020Leak/Splash; Failure to Deliver; Leak/Splash; Failure to Deliver
IT WAS REPORTED THAT SYR 10ML LL W/NDL ECLIPSE 22X1-1/2 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 10864611 ↗MalfunctionJan 27, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND BEFORE USE WITH A SYR 10ML LL W/NDL ECLIPSE 22X1-1/2 RB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "WATER DROP IN THE BARREL." 3 OCCURRENCES WERE REPORTED.
Patient problems: No Patient Involvement
MAUDE report 9630886 ↗MalfunctionApr 1, 2019Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE HAD FOREIGN MATTER. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿THIS PRODUCT HAS BEEN USING FOR QUITE A WHILE IN THIS UNIT. THE USERS COMPLAIN THAT THERE IS OIL IN THE PLUNGER. THE USERS UNDERSTAND THAT SOME OIL IS FOR LUBRICATION. HOWEVER, THE OIL NOW IS TOO MUCH COMPARING WITH THE SAME PRODUCT USED BEFORE."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8469499 ↗MalfunctionMar 8, 2019Physical Resistance/Sticking
IT WAS REPORTED THAT BEFORE USE OF THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM THERE IS A PIECE OF FUZZ STUCK ON THE CATHETER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8404546 ↗MalfunctionMar 8, 2019Contamination /Decontamination Problem
IT WAS REPORTED THAT BEFORE USE OF THE BD LUER-LOK SYRINGE WITH DETACHABLE NEEDLE THERE WAS FOREIGN BODY IN THE BARREL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8404119 ↗MalfunctionJan 16, 2019Contamination /Decontamination Problem
IT WAS REPORTED THAT BEFORE USE OF THE BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE THERE WAS AN ISSUE WITH FOREIGN MATTER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8253572 ↗MalfunctionDec 20, 2018Detachment of Device or Device Component
IT WAS REPORTED WITH THE USE OF THE BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE THERE WAS AN ISSUE WITH SYRINGE NOT BEING FULLY TIGHT WITH NEEDLE. IT WAS REPORTED THAT 50 DEVICES WERE AFFECTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8186840 ↗InjuryJul 17, 2018Leak/Splash
IT WAS REPORTED WHEN ENGAGING THE SAFETY SHIELD OF A BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE BLOOD WENT INTO THE USERS EYES. CUSTOMER REPORTED NO MEDICAL INTERVENTIONS WERE PROVIDED.
Patient problems: Eye Injury
MAUDE report 7694777 ↗MalfunctionDec 15, 2017Material Discolored
IT WAS REPORTED THAT PROPOFOL WAS DRAWN UP INTO THE BD LUER-LOK¿ SYRINGE WITH BD ECLIPSE¿ SAFETY NEEDLE AND TWO BROWN AREAS OF DISCOLORATION WERE OBSERVED INSIDE THE BARREL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7123586 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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