BD Luer-Lok, BD Eclipse 305781Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00382903057818), received between Nov 12, 2018 and Sep 11, 2026 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (4 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.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Break; Activation, Positioning or Separation Problem

  Patient problems: Needle Stick/Puncture

  MAUDE report 50736892 ↗
• MalfunctionSep 18, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT WHILE DRAWING UP VACCINE MEDICINE, THE BD LUER-LOCK¿ SYRINGE WITH ECLIPSE¿ NEEDLE PLUNGER WAS CROOKED AND DIFFICULT TO MOVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DESCRIPTION OF COMPLAINT: WHEN DRAWING UP VACCINATIONS THAT THE PLUNGERS WERE SLIGHTLY COOKED AND THEREFORE COULD NOT BE USED IN THE CLINIC. EVERY PIECE OF THIS ITEM WAS PULLED IMMEDIATELY, SO A NOT TO CAUSE HARM TO ANY PATIENTS OR STAFF. ARE YOU ABLE TO PROVIDE THE DATE OF THE EVENT? BETWEEN THE PERIOD OF AUGUST 3, 2023 TO AUGUST 15, 2023. DID YOU EXPERIENCE ANY ADVERSE EVENTS AS A RESULT OF THIS REPORTED DEFECT? NO. WAS THERE ANY PATIENT IMPACT OR PATIENT INVOLVEMENT? NO".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17770097 ↗
• MalfunctionJun 30, 2022Break; Break

  IT WAS REPORTED THAT THE BD ECLIPSE¿ NEEDLE BROKE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE SMALL PLASTIC PART OF THE SYRINGE BROKE WHILE RN WAS DRAWING UP MEDICATION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14874119 ↗
• MalfunctionMar 29, 2021Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE SYRINGE 3ML LL W/NDL ECLIPSE 25X5/8 RB WAS BLOCKED DURING THE MENINGOCOCCAL B VACCINE INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "CAME FOR 2ND VACCINATION MENINGOCOCCAL B. DURING THE INTRAMUSCULAR VACCINATION IN THE LEFT UPPER ARM, NO FLUID CAME OUT OF THE NEEDLE. A COLLEAGUE WHO WAS ALSO PRESENT DURING THE CONSULTATION LOOKED ON. THIS COLLEAGUE ALSO FELT RESISTANCE WHEN INJECTING THE FLUID. IT WAS NOT POSSIBLE TO INJECT THE VACCINE INTO THE RIGHT ARM. THE NEEDLE WAS REMOVED FROM THE ARM. THIS SAFETY NEEDLE WAS REMOVED AND KEPT FOR A WHILE TO CHECK FOR EFFUSIONS AFTER THE CONSULTATION. (THIS WAS NOT THE CASE) THE VACCINE WAS INJECTED AGAIN IN LEFT UPPER ARM. THIS TIME NO SAFETY NEEDLE WAS USED BUT NEEDLE THAT WAS PROVIDED. INJECTION NOW WENT WITHOUT ANY PROBLEM. PRIOR TO VACCINATION MENINGOCOCCAL FLUID HAD BEEN CHECKED FOR CLARITY, FLUID WAS NOT CLOUDY, VACCINE WAS NOT OVERDUE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11585863 ↗
• MalfunctionJan 4, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT SYRINGE 3ML LL W/NDL ECLIPSE 25X5/8 RB HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:305781, BATCH NO: 0174278. IT WAS REPORTED THAT THE SYRINGE WAS CONTAMINATED.

  Patient problems: No Patient Involvement

  MAUDE report 11114989 ↗
• MalfunctionNov 25, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATTER OCCURRED BEFORE USE WITH A SYRINGE 3ML LL W/NDL ECLIPSE 25X5/8 RB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE ECLIPSE NEEDLE HAD BLACK SPOTS WHEN OPENED. GOOD AFTERNOON ALL, I RECENTLY DISCOVERED A NEEDLE THAT IS NOT STERILE AT MY CLINIC. I OPENED THE NEEDLE TO GIVE A INFLUENZA VACCINES AND SAW BLACK SPOTS OVER THE OPENING AND INSIDE THE OPENING . LOT NUMBER IS 9114863 AND THE EXPIRATION DATE 4/30/24. I AM UNSURE OF ANY OTHER SITES HAVE HAD THIS CONCERNS BUT WANTED TO LET YOU GUYS KNOW."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9371730 ↗
• MalfunctionNov 21, 2019Complete Blockage; Complete Blockage

  IT HAS BEEN REPORTED THAT THE SYRINGE 3ML LL W/NDL ECLIPSE 25X5/8 RB HAS BEEN FOUND CLOGGED DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE NEEDLE IS CLOGGED. VERBATIM: DURING A SEVERAL DAY FLU SHOT CLINIC WE HAVE ENCOUNTERED 5 NEEDLES WHERE THE NEEDLE IS CLOGGED AND CANNOT LOAD THE SYRINGE WITH THE SERUM. THE SYRINGE IS FINE ITS SPECIFICALLY THE NEEDLE THAT IS CLOGGED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9355341 ↗
• MalfunctionNov 5, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD LUER-LOK¿ SYRINGES WITH DETACHABLE ECLIPSE¿ NEEDLES LEAKED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305781, BATCH NO: UNKNOWN. IT WAS REPORTED THAT LEAK WAS OBSERVED BETWEEN THE SYRINGE AND EXTENSION SET. THE LEAK WAS OBSERVED BETWEEN BD ECLIPSE AND EXTENSION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9279844 ↗
• InjuryOct 2, 2019Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT HAS BEEN REPORTED THAT THE SYRINGE 3ML LL W/NDL ECLIPSE 25X5/8 RB HAS BEEN FOUND EXPERIENCING SAFETY MECHANISM FAILURE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE HEALTH CARE PROVIDER RECEIVED A NEEDLE STICK INJURY AFTER THE SAFETY SHIELD BROKE OFF. VERBATIM: ISSUE WITH 3ML 25G 5/8¿ BD ECLIPSE NEEDLES. ONE OF OUR STAFF HAD A NEEDLE STICK INJURY WHEN ACTIVATING THE SAFETY SHIELD. THE SAFETY SHIELD WENT SIDEWAYS WHEN PUSHED AND BROKE OFF CAUSING THE NURSE¿S THUMB TO SCRAPE ACROSS THE USED NEEDLE. DEFECTIVE PRODUCT WAS NOT RETAINED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 9146696 ↗
• InjuryAug 16, 2019Device Slipped

  IT WAS REPORTED THAT CAPS ARE NOT STAYING ON NEEDLE AND HEATH CARE WORKERS ARE RECEIVING NEEDLE STICK INJURIES WITH A BD SYRINGE 3ML LL W/NDL ECLIPSE 25X5/8 RB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (1 OF 3) IT WAS REPORTED THAT THE NEEDLE CAPS ARE NOT STAYING ON SECURELY RESULTING IN NEEDLE STICKS TO STAFF. ADDITIONAL INFORMATION FROM REPORTER: I HAVE HAD MULTIPLE STICKS TO STAFF MEMBERS BECAUSE THE NEEDLE CAPS DO NOT STAY ON SECURELY. THE PACKAGES IS ALSO MORE FRAGILE. WHEN RIPPING THE NEEDLES FROM THE PERFORATED LINES WE TEND TO OPEN THE ACTUAL PACKAGE AND HAVE TO DISCARD THE THEN EXPOSED/NON STERILE NEEDLE. THIS HAS BEEN GOING ON FOR A FEW MONTHS BUT WITH MORE STICKS AND CONVERSATIONS WITH STAFF MEMBERS (MEDICAL ASSISTANTS AND NURSES) I HAVE BEEN MADE AWARE THIS IS A PRETTY CONSISTENT THING.

  Patient problems: Needle Stick/Puncture

  MAUDE report 8900773 ↗
• MalfunctionJul 23, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO USE FOREIGN MATTER WAS DISCOVERED WHEN PLUNGER WAS PULLED BACK WITH A BD SYRINGE 3ML LL W/NDL ECLIPSE¿ 25X5/8 RB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (1 OF 2) IT WAS REPORTED THAT WHEN THE PLUNGER IS PULLED BACK YOU CAN SEE A RING OF CONDENSATION WHERE THE PLUNGER WAS AT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8819388 ↗
• MalfunctionNov 12, 2018Device Contamination with Chemical or Other Material

  IT WAS REPORTED WITH THE USE OF THE BD ECLIPSE¿ BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE THERE WAS AN ISSUE WITH FOREIGN MATTER. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8061903 ↗