BD Eclipse™ Needle with SmartSlip™ Technology 305760Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 00382903057603), received between Feb 19, 2018 and Mar 11, 2026 — classified as 7 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (14 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 25 most recent of 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2026Crack; Material Integrity Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24571374 ↗
• MalfunctionNov 13, 2025Leak/Splash; Connection Problem; Leak/Splash; Connection Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23551162 ↗
• MalfunctionNov 13, 2025Leak/Splash; Connection Problem; Leak/Splash; Connection Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23551161 ↗
• MalfunctionSep 19, 2025Leak/Splash; Connection Problem; Leak/Splash; Connection Problem

  DATE OF INCIDENT (YYYY-MM-DD): (B)(6) 2025. AHS OPTIONAL REPORT TO CMDSNET (HEALTH CANADA): INCIDENT DETAILS: ATTEMPTED TO ATTACH THE 5/8 BD ECLIPSE NEEDLE TO THE MMRVAR SYRINGE AND IT WAS CHALLENGING TO GET THE HUB OF THE NEEDLE TO SECURE ONTO THE MMRVAR SYRINGE. IN FACT, THE ADJOINING PART OF THE MMRVAR SYRINGE STARTED TO COME AWAY FROM THE SYRINGE. WHEN IT DID JOIN IT WAS CROOKED AND WOBBLY. SHOWED SAME TO CDN, SHE ADVISED TO ATTEMPT TO TRY ANOTHER NEEDLE. SAME DONE AND JOIN AND NEEDLE FELT STABLE AND SECURE. PRIMED NEEDLE NO LEAKAGE NOTED. THEN ADMINISTERED VACCINE AT WHICH POINT VACCINE WAS LEAKING OUT OF THE JOIN AREA. WITHDREW NEEDLE AND REPORTED TO PARENT AND CDN. CONFIRMED WITH CDN AS TO HOW TO PROCEED, CONFIRMED SAME WITH IPSM. RE ADMINISTERED MMRVAR VACCINE IN THE OTHER LIMB. THERE WAS NO SERIOUS HARM REPORTED. 9/13 CUSTOMER RESPONSE. YES. THE DOSE NEEDED TO BE REPEATED IN THE OTHER LIMB, NO REPORTED ADVERSE EVENTS TO THE NURSE OR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23101658 ↗
• MalfunctionAug 11, 2025Material Integrity Problem; Material Integrity Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22777955 ↗
• MalfunctionAug 11, 2025Connection Problem; Connection Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22777953 ↗
• MalfunctionJul 24, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A COUPLE OF DROPS LEAKED FROM THE SYRINGE - CAUGHT BY GAUZE ( THIS WAS DISPOSED OF IN AN APPROPRIATE SHARPS BIN). THE LEAK APPEARED TO COME FROM WHERE THE NEEDLES LEUR LOCK WAS ATTACHED TO THE LEUR LOCK OF THE SYRINGE. NO HARM TO PATIENT. ONE OF OUR NURSES HAVE REPORTED A FEW DROPS OF MEDICATION HAD LEAKED FROM THE CONNECTION BETWEEN THE BD ECLIPSE NEEDLE AND THE LEUR LOCK SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22595577 ↗
• MalfunctionJul 24, 2025Break; Break

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE SAFETY SHIELD BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SAFETY IS VERY POOR QUALITY AND RIPS OFF EASILY. THERE IS A HUGE POTENTIAL FOR INJURY WHEN USING THESE SUBOPTIMAL PRODUCTS. DATE OF INCIDENT: 2025-06-17. 7/21/2025: COULD YOU PLEASE CONFIRM IF YOU NOTICED ANY LEAKAGE? THIS IS A GENERAL REPORT OF QUALITY/USABILITY OF THE PRODUCT VS BEING RELATED TO A SPECIFIC EVENT. WAS THERE ANY HARM/SERIOUS INJURY TO PATIENT OR HCP DIRECTLY RELATED TO THIS REPORTED EVENT(S)? IF YES, PLEASE PROVIDE DETAILS INCLUDING ANY DIAGNOSTICS OR TREATMENT THAT WAS PROVIDED. NO HARM, THIS IS REPORTED AS A HAZARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22592653 ↗
• MalfunctionJun 20, 2025Failure to Align; Mechanics Altered; Failure to Align; Mechanics Altered

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE SAFETY MECHANISM DID NOT ALIGN/LOCK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DATE OF INCIDENT: (B)(6) 2025. LEVEL OF HARM: NO APPARENT HARM - REACHED THE PATIENT/PERSON -- INCONVENIENT. INCIDENT DETAILS: CLOSE CALL FOR NEEDLESTICK INJURY. ATTEMPTED TO USE NEEDLE SAFETY. MECHANISM AFTER IMMUNIZATION USING THUMB WHILE NOT LOOKING AT SYRINGE/NEEDLE, FELT THAT SAFETY MECHANISM WAS NOT LOCKING TO COVER NEEDLE SECURELY, LOOKED AT NEEDLE AND SAW PINK NEEDLE SHIELD WAS BENT A LITTLE SIDEWAYS (?CAME OFF ITS LATCH? I DID NOT HAVE THE CHANCE TO INSPECT) LEADING TO BE UNABLE TO COVER OVER NEEDLE. USED COUNTERTOP TO ADJUST NEEDLE SHIELD TO CENTER/STRAIGHTEN UP AND CLOSE ONTO NEEDLE. POTENTIAL FAULTY NEEDLE FROM BATCH AS NEEDLE SHIELD DOES NOT COME OFF FROM ITS LATCH EASILY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22302698 ↗
• MalfunctionMay 30, 2025Fluid/Blood Leak; Connection Problem; Fluid/Blood Leak; Connection Problem

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE POOR CONNECTION NEEDLE TO SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BD ECLIPSE NEEDLE NO LONGER SECURELY LEUR LOCKS IN WITH THE BD 3ML SYRINGE (OFTEN USED TOGETHER BY NURSES TO DELIVER SUBCUTANEOUS INJECTION/MEDICATIONS). THE CONCERN IS THAT THE CONNECTION POINT WILL DISCONNECT AT THE POINT OF INJECTION CAUSING POTENTIAL BLOOD AND BODY FLUID EXPOSURE/INJURY OR LOSS/INCORRECT DOSING OF MEDICATION. AT THE TIME OF THE INITIAL CONTACT DIFFICULTY ATTACHING THE SYRINGE TO THE NEEDLE COULD ALSO CAUSE INJURY AND LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22119265 ↗
• MalfunctionMay 26, 2025Break; Break

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22084929 ↗
• MalfunctionMay 16, 2025Leak/Splash; Connection Problem; Leak/Splash; Connection Problem

  ADDITIONAL INFO: 1. WAS THERE ANY MEDICATION LEAK NOTICED? WITH WHATEVER MEDICATION MIGHT BE BEING DRAWN UP ¿ NOT SPECIFIC. 2. CAN YOU PROVIDE DATE ISSUE IDENTIFIED ON 4 NEEDLES? (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035419 ↗
• MalfunctionMay 16, 2025Leak/Splash; Connection Problem; Leak/Splash; Connection Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035348 ↗
• MalfunctionJan 15, 2025Break; Break

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE NEEDLE BROKE OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: DURING THE PERIOD OF ADMINISTERING THE FLU SHOT BY THE HEALTHCARE INSTITUTIONS, WE RECEIVED A COMPLAINT ABOUT ONE OF YOUR ITEMS. I HAD 2X THAT THE PROTECTIVE COVER FLEW OFF WHILE I WANTED TO PUT IT ON. AND A COLLEAGUE HAD 1X THAT THE NEEDLE BROKE OFF ITSELF AT THE PROTECTIVE COVER. FORTUNATELY, NO INCIDENTS HAVE ARISEN FROM IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21163478 ↗
• MalfunctionJan 15, 2025Separation Problem; Separation Problem

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE SAFETY SHIELD BROKE OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: DURING THE PERIOD OF ADMINISTERING THE FLU SHOT BY THE HEALTHCARE INSTITUTIONS, WE RECEIVED A COMPLAINT ABOUT ONE OF YOUR ITEMS. I HAD 2X THAT THE PROTECTIVE COVER FLEW OFF WHILE I WANTED TO PUT IT ON. AND A COLLEAGUE HAD 1X THAT THE NEEDLE BROKE OFF ITSELF AT THE PROTECTIVE COVER. FORTUNATELY, NO INCIDENTS HAVE ARISEN FROM IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21163465 ↗
• MalfunctionSep 29, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE S/T NEEDLE SLIPS OFF THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN TO ENGLISH: WE FORWARD THE COMPLAINT REPORT FOR THE PRODUCT 50338767-HYPODERMIC NEEDLE W/DISP. SAFETY TEST 25G 5/8 16 MM ECLIPSE REF. 305760 AS THE NEEDLE SLIPS OFF THE CONNECTOR ATTACHMENT FOR THE RECONSTITUTION OF CHEMOTHERAPY DRUGS UNLIKE NEEDLES WITHOUT SAFETY EVEN OF THE SAME BRAND. 5SEP2024 ON 3 SEPTEMBER THERE WAS A DISLOCATION OF THE NEEDLE INDICATED BY A FITTING FOR THE RECONSTITUTION OF CHEMOTHERAPY DRUGS (BOTH PRODUCED WITH THE LUER-LOCK SYSTEM). WE TESTED THE SYSTEM ON A SYRINGE WITH SALINE SOLUTION AND WE REALIZED THE INCOMPATIBILITY BETWEEN THE FITTING AND THE NEEDLE ITSELF, WHICH DID NOT HAPPEN WITH THE PREVIOUS STANDARD NEEDLES (SAME CHARACTERISTICS) OF YOUR BRAND THAT DO NOT HAVE THE SAFETY SYSTEM. HOWEVER, NO ADVERSE EVENTS HAVE BEEN REPORTED ON OPERATORS OR PATIENTS, NOR ENVIRONMENTAL CONTAMINATION WITH ANTIBLASTIC DRUGS. A FURTHER SIGN THAT THE FITTING IS FROM ANOTHER SUPPLIER, BUT AS ALREADY EXPLAINED, YOUR NEEDLES WITHOUT SAFETY ARE PERFECTLY COMPATIBLE. ¿ HAVE THERE BEEN ANY IMPACTS ON THE PATIENT (SE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20330249 ↗
• MalfunctionJul 3, 2024Break; Break

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE S/T 25X5/8 RB NEEDLE SHIELD BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: DESCRIPTION OF THE FACTS BY THE IDE: "AFTER GIVING A SUBCUTANEOUS TREATMENT TO A PATIENT, I WANTED TO CLOSE WITH THE SAFETY OF THE NEEDLE BUT IT BROKE IN TWO AND THE NEEDLE TWISTED" THERE WERE NO CLINICAL CONSEQUENCES OR AES FOLLOWING THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19666609 ↗
• InjuryJun 11, 2024Crack; Leak/Splash; Crack; Leak/Splash

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE S/T 25X5/8 RB WAS CRACKED AT THE LUER CONNECTION AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN TO ENGLISH: UPON THE INJECTION OF THE MPRV VACCINE (PROQUAD) THE PART THAT CONNECTS THE NEEDLE TO THE SYRINGE WAS DEFECTIVE (CRACKING) THEREFORE IT WAS NOT POSSIBLE TO QUANTIFY THE DOSE OF VACCINE ACTUALLY ADMINISTERED SINCE PART OF IT LEAKED.

  Patient problems: Insufficient Information

  MAUDE report 19515654 ↗
• InjuryJan 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BD ECLIPSE NEEDLE STICK INJURY OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: I WOULD LIKE TO INFORM YOU THAT ONE OF OUR NURSES HAS REPORTED A MATERIAL SAFETY EVENT. IT CONCERNS A BD ECLIPSE NEEDLE. IN FACT, WHEN OUR NURSE DISASSEMBLED A SYRINGE FROM HER NEEDLE, WITH THE SAFETY DEVICE IN PLACE BEFOREHAND, SHE STILL PRICKED HERSELF. THIS EVENT HAD MAJOR AND IMMEDIATE CONSEQUENCES FOR THE CAREGIVER: AN AES.

  Patient problems: Insufficient Information

  MAUDE report 18551288 ↗
• InjurySep 20, 2023Break; Retraction Problem; Break; Retraction Problem

  IT WAS REPORTED THAT WHILE USING THE BD ECLIPSE¿ NEEDLE THE SAFETY BROKE OFF AND HCP WAS PRICKED WITH EXPOSED NEEDLE. THE FOLLOWING WAS TRANSLATED FROM FRENCH TO ENGLISH: ACCIDENT FOLLOWING A SUBCUTANEOUS INJECTION. AFTER THE INJECTION, I PUT THE SAFETY IN PLACE, THEN WHEN I WAS ABOUT TO THROW THE NEEDLE INTO THE DARSI, THE SAFETY CAME OFF AND I ACCIDENTALLY PRICKED THE THUMB OF MY RIGHT HAND.

  Patient problems: Needle Stick/Puncture

  MAUDE report 17785872 ↗
• MalfunctionJul 6, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT DURING USE WITH AN UNSPECIFIED AMOUNT OF BD ECLIPSE¿ NEEDLE THE NEEDLE WAS BLOCKED. PATIENT HAS TO BE INJECTED SEVERAL TIMES AS NEEDLE IS REPLACED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: THE DEPARTMENT REPORTS THAT AFTER SEVERAL INJECTIONS OF VIDAZA (AZACITIDINE), THE SUBCUTANEOUSLY INJECTED PRODUCT REGULARLY FAILS TO INJECT, AND THAT EVEN INCREASING THE INJECTION PRESSURE OR ASPIRATING THE PRODUCT DOES NOT CHANGE ANYTHING. THE PATIENT MUST THEREFORE BE INJECTED SEVERAL TIMES WITH THE SAME SYRINGE, BUT WITH A DIFFERENT NEEDLE. EVEN WITH THIS CHANGE, THE PRODUCT STILL HAS TROUBLE GETTING THROUGH. THE DEPARTMENT POINTS OUT THAT STAFF RESPECT THE PROCEDURES FOR INJECTING THE PRODUCT AND STORING IT IN THE DEPARTMENT (ROOM TEMPERATURE 30 MINUTES BEFORE INJECTION, ETC.), AND THAT IN THE PAST THEY USED OTHER 25 G NEEDLES, AND THIS DID NOT HAPPEN. THE MATERIAL WAS NOT KEPT.

  Patient problems: Needle Stick/Puncture

  MAUDE report 17276144 ↗
• MalfunctionJun 9, 2023Packaging Problem; Packaging Problem

  IT WAS REPORTED WHILE USING BD ECLIPSE NEEDLE WITH SMARTSLIP THERE WERE STERILITY ISSUES THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: WE FOUND A DEFECT ON THE STERILITY OF THE NEEDLES REF (B)(4) . THE CONCERNED LOT 2112013. WE HAVE THESE NEEDLES AVAILABLE AT THE PHARMACY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17096884 ↗
• InjuryJun 1, 2023Break; Break

  IT WAS REPORTED THAT THE BD ECLIPSE¿ NEEDLE SAFETY MECHANISM DETACHED AND THE NEEDLE PRICKED THE NURSE'S HAND. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE DEPARTMENT REPORTS THAT THE SUBCUTANEOUS NEEDLE SECURING ELEMENT DETACHED FROM THE REST OF THE NEEDLE WHEN SECURING THE NEEDLE AFTER INJECTION OF THE PRODUCT DARATUMUMAB (MONOCLONAL ANTIBODY BY SUBCUTANEOUS ROUTE). THE NEEDLE TWISTED, PIERCED THE INDIVIDUAL PROTECTIVE GLOVE AND PRICKED THE NURSE'S HAND.

  Patient problems: Needle Stick/Puncture

  MAUDE report 17038172 ↗
• MalfunctionFeb 18, 2022Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  IT WAS REPORTED WHILE USING BD ECLIPSE NEEDLE WITH SMARTSLIP THE NEEDLE DETACHED FROM THE SYRINGE AND LEAKED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿DURING FIXING THE SAFETY-NEEDLE THE LLA GOT LOOSE AND FINALLY DETACHED FROM THE TIP. FOR THIS REASON THE SOLUTION LEAKED BETWEEN THE TIP AND THE NEEDLE. THE DOSE WAS NOT ADMINISTERED TO THE PATIENT¿.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13560042 ↗
• MalfunctionOct 29, 2021Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED 2 BD NEEDLE ECLIPSE S/T 25X5/8 RB HAD BROKEN SAFETY MECHANISMS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TWICE TODAY A NURSE WENT TO CLICK THE SAFETY DEVICE AND BOTH TIMES IT BROKE OFF OR FELL RIGHT OFF THE HUB OF THE NEEDLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12724853 ↗