BD Eclipse™ Needle with SmartSlip™ Technology 305891Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 00382903058914), received between Feb 20, 2018 and Dec 29, 2025 — classified as 2 injuries, 49 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (22 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 51 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 29, 2025Leak/Splash; Connection Problem; Leak/Splash; Connection Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23914191 ↗
• MalfunctionDec 22, 2025Connection Problem; Connection Problem

  THERE IS A RING IN THE CANNULA ATTACHMENT, WHICH CAN ONLY BE PRESSED IN BY FORCE ON SOME CANNULAS AND CAN BE PROPERLY CONNECTED TO THE SYRINGE CONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23870666 ↗
• MalfunctionMay 12, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE SAFETY MECHANISM FAILURE WITH NEEDLESTICK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLESTICK INJURY DUE TO THE PINK SAFETY CAP NOT WORKING PROPERLY ON THE SHORT 24G ORANGE NEEDLES.

  Patient problems: Needle Stick/Puncture

  MAUDE report 22006776 ↗
• MalfunctionMay 12, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE SAFETY MECHANISM FAILURE WITH NEEDLESTICK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLESTICK INJURY DUE TO THE PINK SAFETY CAP NOT WORKING PROPERLY ON THE SHORT 24G ORANGE NEEDLES.

  Patient problems: Needle Stick/Puncture

  MAUDE report 22006775 ↗
• MalfunctionMay 12, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE SAFETY MECHANISM FAILURE WITH NEEDLESTICK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLESTICK INJURY DUE TO THE PINK SAFETY CAP NOT WORKING PROPERLY ON THE SHORT 24G ORANGE NEEDLES.

  Patient problems: Needle Stick/Puncture

  MAUDE report 22006489 ↗
• MalfunctionMar 27, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE S/T SAFETY MECHANISM DID NOT ENGAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: ON (B)(6) 2025, WHILE TAKING A BLOOD GAS SAMPLE, THE NURSE WAS UNABLE TO ENGAGE THE SAFETY DEVICE ON THE HYPODERMIC CANULA. SHE DESCRIBED RESISTANCE WHEN LOWERING THE SAFETY DEVICE. THE NURSE THEN TRIED TO LOWER THE SAFETY CATCH WITH HER SECOND HAND. THE SAFETY CATCH THEN DISENGAGED FROM THE CANULA. THE CANULA PENETRATED THE GLOVE AND PRICKED THE NURSE, RESULTING IN A BLOOD EXPOSURE ACCIDENT. THE DEFECTIVE DEVICE WAS NOT KEPT BY THE NURSE. THE NURSE WAS CONSULTED IN THE HOSPITAL'S EMERGENCY DEPARTMENT FOLLOWING THE BLOOD EXPOSURE ACCIDENT. MEDICAL FOLLOW-UP HAS BEEN ORGANIZED. AT PRESENT, NO POST-EXPOSURE PROPHYLAXIS HAS BEEN INITIATED, GIVEN THE NEGATIVE VIROLOGICAL STATUS OF THE PATIENT SAMPLED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 21709688 ↗
• MalfunctionOct 31, 2024Break; Break

  NO ADDITIONAL INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 20580099 ↗
• MalfunctionOct 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE SAFETY SHIELD FALLS OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: REASON FOR THE COMPLAINT: THE SAFETY CAP FALLS OFF MANY CANNULAS. INCIDENT OCCUR - DURING USE

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

  MAUDE report 20507902 ↗
• MalfunctionApr 30, 2024Break; Break

  MATERIAL#: 305891 BATCH NUMBER#: 2202004 IT WAS REPORTED BY CUSTOMER THAT WHEN USING THE PRODUCT WITH VACCINES IN GLASS PREFILLED SYRINGES WE HAVE FOUND THAT THESE NEEDLES DON¿T WORK DUE TO THE AMOUNT OF PRESSURE NEEDED TO TWIST THE TIP ON THE LUER LOCK SYSTEM. WHAT HAPPENS IS THAT THE GLASS PREFILLED SYRINGES HAVE A LUER LOCK ADAPTER THAT BREAKS OFF WHEN TRYING TO USE THESE NEEDLE TIPS DUE TO THE PRESSURE NEEDED TO SECURE THE NEEDLE TIP TO THE BARREL.I WAS WONDERING IF YOU STILL OFFER 1¿ NEEDLE TIPS OF THE SAME STYLE WITHOUT THE SMART SLIP FOR THIS PURPOSE. VERBATIM#: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. I AM REACHING OUT REGARDING A PROBLEM WE HAVE ENCOUNTERED AT OUR LOCAL HEALTH UNIT WHEN USING THE BD ECLIPSE NEEDLE WITH SMART SLIP TECHNOLOGY. WHEN USING THIS PRODUCT WITH VACCINES IN GLASS PREFILLED SYRINGES WE HAVE FOUND THAT THESE NEEDLES DON¿T WORK DUE TO THE AMOUNT OF PRESSURE NEEDED TO TWIST THE TIP ON THE LUER LOCK SYSTEM. WHAT HAPPENS IS THAT THE GLASS PREFILLED SYRINGES HAVE A LUER LOCK ADAPTER THAT BREAKS OFF WHEN TRYING TO USE THESE NEEDLE TIPS DUE TO THE PRESSURE NEEDED TO SECURE THE NEEDLE TIP TO THE BARREL.I WAS WONDERING IF YOU STILL OFFER 1¿ NEED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19211909 ↗
• MalfunctionApr 29, 2024Break; Break

  MATERIAL#: UNKNOWN, BATCH NUMBER#: 2202004. IT WAS REPORTED BY CUSTOMER THAT WHEN USING THE PRODUCT WITH VACCINES IN GLASS PREFILLED SYRINGES WE HAVE FOUND THAT THESE NEEDLES DON¿T WORK DUE TO THE AMOUNT OF PRESSURE NEEDED TO TWIST THE TIP ON THE LUER LOCK SYSTEM. WHAT HAPPENS IS THAT THE GLASS PREFILLED SYRINGES HAVE A LUER LOCK ADAPTER THAT BREAKS OFF WHEN TRYING TO USE THESE NEEDLE TIPS DUE TO THE PRESSURE NEEDED TO SECURE THE NEEDLE TIP TO THE BARREL.I WAS WONDERING IF YOU STILL OFFER 1¿ NEEDLE TIPS OF THE SAME STYLE WITHOUT THE SMART SLIP FOR THIS PURPOSE. WE FIRST DISCOVERED THE ISSUE ON (B)(6) 2024 AND THE PRODUCT NUMBER IS# 305891. WE WASTED MULTIPLE DOSES OF VACCINE IN PREFILLED SYRINGES ON THIS DATE AND ALSO HAD A SITUATION (ON THE SAME DAY) IN WHICH A PREFILLED SYRINGE LOOKED FINE BUT ACTUALLY LEAKED FLUID DURING ADMINISTRATION OF THE VACCINE ONTO THE SKIN (THUS CLIENT DID NOT RECEIVE A FULL DOSE AS INTENDED). I SUSPECT THAT THE LUER LOCK PIECE ON THE VIAL MIGHT HAVE PARTIALLY DISCONNECTED WHEN PUTTING ON THE NEEDLE TIP AND THUS THAT ALLOWED LEAKAGE-ALTHOUGH THIS WAS NOT SOMETHING THAT YOU COULD SEE BY LOOKING AT IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19200958 ↗
• MalfunctionJun 13, 2023Break; Break

  IT WAS REPORTED THAT AFTER USE WITH THE BD ECLIPSE¿ NEEDLE THE SAFETY CAP DETACHED. THERE WAS NO REPORT OF PATIENT OR USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PROTECTION CAP OF THE BD ECLIPSE NEEDLE BROKE OFF WHEN THEY WANTED TO PLACE IT OVER THE NEEDLE AFTER USAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17121776 ↗
• MalfunctionMay 18, 2023Contamination; Contamination

  IT WAS REPORTED WHILE USING BD MICROLANCE¿3 NEEDLES FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE HAIR WAS SHRINK-WRAPPED IN TWO STERILE PACKAGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16951004 ↗
• MalfunctionMar 27, 2023Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE BD ECLIPSE¿ SAFETY NEEDLE SAFETY PART BECAME LOOSE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: AT AN INSTITUTION WE HAVE RECEIVED COMPLAINTS FROM 3 DIFFERENT DEPARTMENTS THAT THE SAFETY PART OF THE NEEDLE HAS COME LOOSE. ALL THREE REPORTS CONCERN PRODUCT WITH LOT NUMBER 2206002, SEE ALSO THE PICTURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16618428 ↗
• MalfunctionMar 21, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT VACCINE MEDICATION LEAKED OUT OF THE BD ECLIPSE¿ SAFETY NEEDLE DURING USE DUE TO A BAD CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THESE ARE THE ORANGE NEEDLES WITH ITEM NUMBER 305891 AND LOT NUMBER 2211001. THESE HAVE A BAD CONNECTION, RESULTING IN VACCINE REGULARLY RUNNING DOWN THE NEEDLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16585576 ↗
• MalfunctionMar 21, 2023Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE BD ECLIPSE¿ SAFETY NEEDLE SAFETY PART BECAME LOOSE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: AT AN INSTITUTION WE HAVE RECEIVED COMPLAINTS FROM 3 DIFFERENT DEPARTMENTS THAT THE SAFETY PART OF THE NEEDLE HAS COME LOOSE. ALL THREE REPORTS CONCERN PRODUCT WITH LOT NUMBER 2206002, SEE ALSO THE PICTURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16585294 ↗
• MalfunctionMar 16, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD ECLIPSE¿ SAFETY NEEDLE CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE WAS ATTACHED TO SYRINGE WITHOUT ANY OBVIOUS DEFORMITY, WRITER ABLE TO PRIME SYRINGE. ATTEMPTED TO INJECT CLIENT WITH VACCINE, PLUNGER WOULD NOT INJECT DESPITE FIRM PRESSURE APPLIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16554859 ↗
• MalfunctionFeb 8, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT THE SAFETY MECHANISM DISCONNECTED FROM THE BD ECLIPSE¿ SAFETY NEEDLE WHEN REMOVING IT FROM THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE SAFETY DEVICE ON A 1IN NEEDLE WAS DISCONNECTED UPON REMOVING IT FROM THE PACKAGING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16318799 ↗
• MalfunctionNov 30, 2022Break; Break

  IT WAS REPORTED WHILE USING BD ULTRA-FINE¿ PEN NEEDLES 31G X 5MM (105 COUNT) THE CANNULA BROKE OFF. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: USER REPORT_29497_22 NEEDLES BREAK OFF AFTER APPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15891345 ↗
• MalfunctionOct 6, 2022Leak/Splash; Fitting Problem; Leak/Splash; Fitting Problem

  IT WAS REPORTED WHILE USING BD ECLIPSE¿ SAFETY NEEDLE THE NEEDLE AND SYRINGE COULD NOT CONNECT PROPERLY AND LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT.THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PUSHING TOGETHER THIS NEW NEEDLE AND THE VACCINE TOOK LOTS OF EFFORT AND IN A FINAL EFFORT TO PUSH IT ONTO THE INFANRIX HEXA SYRINGE MY GRIP SLIPPED AND THE PLUNGER WAS DEPRESSED CAUSING VACCINE SPILLAGE AND SUBSEQUENT WASTAGE OF VACCINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15556465 ↗
• MalfunctionAug 26, 2022Leak/Splash; Shielding Failure; Leak/Splash; Shielding Failure

  IT WAS REPORTED THAT AT LEAST THREE BD ECLIPSE¿ NEEDLES EXPERIENCED SAFETY SHIELD LOOSENING AND LEAKAGE. THIS OCCURRED WITH 3 NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLESTICK INCIDENTS: THE CONNECTION PIECE WITH THE NEEDLE IS COMING LOOSE FROM EACH OTHER. FROM THIS BOX, WHICH HAS JUST BEEN OPENED, THIS HAS HAPPENED TO 3 NEEDLES. IT CONCERNS LOT NUMBER 2112006 AND IT CONCERNS 3 PCS FROM THE SAME BOX. ACCORDING TO ME, THE CUSTOMER HAS KEPT THE BOX. WE DO NOT KNOW IF THEY HAVE KEPT THE SAMPLES WITH WHICH THIS COMPLAINT HAS OCCURRED. WERE THERE CONSEQUENCES FOR THE PATIENT/CARER/USER? THE CONSEQUENCES WERE THAT IT IS ANNOYING WHEN A VACCINATION DOES NOT GO SMOOTHLY FOR A SMALL CHILD. 2ND PRICK. WERE THERE ANY NEGATIVE CONSEQUENCES ASSOCIATED WITH THIS EVENT? CONFIDENCE IN THE SOUNDNESS OF THE MATERIAL HAS BEEN SHAKEN. WAS IT A PURE NEEDLESTICK INJURY? IN HINDSIGHT, IT DOES NOT APPEAR TO HAVE BEEN A NEEDLESTICK INCIDENT BUT RATHER A LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15307371 ↗
• MalfunctionJan 25, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED WHILE USING BD ECLIPSE¿ SAFETY NEEDLE A NEEDLE DETACHED FROM THE HUB. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ISSUE WITH CONNECTION OF SAFETY NEEDLE TO SYRINGES. NOT SECURE ENOUGH. INCIDENT WHERE NEEDLE HAS COME FREE AND PRICKED A STAFF MEMBER (THIS WAS DURING A DEMONSTRATION OF THE FAULT IN THE OFFICE ENVIRONMENT- NOT NEEDLE-STICK INJURY, NEAR MISS).

  Patient problems: Needle Stick/Puncture

  MAUDE report 13342466 ↗
• MalfunctionNov 23, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BD ECLIPSE¿ NEEDLE EXPERIENCED DEVICE DAMAGE WHILE STILL CONSIDERED OPERABLE, AND NEEDLE AND SYRINGE SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER ADMINISTERING THE VACCINE TO CLIENT, I ACTIVATED SAFETY MECHANISM ON THE NEEDLE AND AS I PUSHED IT CLOSED, THE CAP AND NEEDLE CAME OFF AND FELT THE TIP OF THE SYRINGE BREAK.. NO HARM WAS DONE TO ME OR THE CLIENT BUT IF THE CLIENT WAS CLOSER TO ME I FEEL THAT THE GLASS THAT BROKE WOULD HAVE HIT HER IN THE ARM. I BELIEVE IT WAS THE NEEDLE THAT CAUSED THE SYRINGE TO BREAK - MAYBE IT WAS PUT ON TOO TIGHT LEVEL OF HARM? -NO EFFECT - DID NOT REACH PATIENT - DETECTED BEFORE USE OR DOES NOT TOUCH PERSON DURING USE. WHO WAS AFFECTED? -NO PERSON AFFECTED. UNEXPECTED OR PROLONGED CARE? -NO. FREQUENCY OF PROBLEM: -FIRST TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12866145 ↗
• MalfunctionSep 13, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED WHEN USING THE BD ECLIPSE¿ SAFETY NEEDLE THE NEEDLE HUB HAD A HOLE WAS CRACKED OR DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE PLASTIC ON THE NEEDLE HUB IS MISSHAPEN, UNABLE TO ATTACH THE NEEDLE TO THE SYRINGE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12464578 ↗
• MalfunctionSep 1, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE 25 G X 1 IN. ECLIPSE NEEDLE SMARTSLIP EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILST ADMINISTERING A SUBCUTANEOUS INJECTION OF BORTEZOMIB (3MG IN 1.2ML) WHEN INCIDENT REPORTER AND THE PATIENT FELT A DRIBBLE NEAR THE INJECTION SITE. THEY REALIZED THAT SOME OF THE MEDICATION HAD LEAKED BETWEEN THE SYRINGE AND NEEDLE. THE NEEDLE CANNOT HAVE BEEN FULLY SCREWED/FITTED INTO THE SYRINGE. IT IS NOT POSSIBLE TO DETERMINE HOW MUCH OF THE 1.2ML LEAKED OUT. THERE HAVE BEEN ISSUES WITH THIS BATCH OF ORANGE NEEDLES BD ECLIPSE WITH SMARTSLIP TECHNOLOGY 25G. WASHED THE PATIENT'S HAND AND STOMACH THOROUGHLY WITH SOAP AND WATER AND RINSED AND DRIED BOTH TOO. BORTEZOMIB IS NEUTRAL AND NOT AN IRRITANT OR VESICANT. EXPLAINED TO THE PATIENT THAT BORTEZOMIB IS NOT A CHEMOTHERAPY AND IS NOT LIKELY TO CAUSE ANY SKIN IRRITATION, BUT IT WAS IMPORTANT TO CLEANSE THE SKIN. I TOLD HIM TO MONITOR HIS SKIN AND STOMACH FOR ANY SIGNS OF IRRITATION AS A PRECAUTION. THE PATIENT ASKED IF THE TREATMENT WOULD NEED RE-DOING. TOLD PATIENT NO AS IT WAS NOT POSSIBLE TO DETERMINE HOW MUCH LEAKED OUT AND WHAT DOSE WAS GIVEN. WE DID NOT WANT TO GIVE TOO MUCH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12407963 ↗
• MalfunctionAug 25, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ECLIPSE¿ NEEDLE EXPERIENCED LEAKAGE AT THE CONNECTION SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE DRAWING VACCINE, WRITER NOTICED LEAKAGE AT BASE OF NEEDLE AND VACCINE WAS WASTED. LEVEL OF HARM: NO EFFECT - DID NOT REACH PATIENT - DETECTED BEFORE USE OR DOES NOT TOUCH PERSON DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12367894 ↗