BD Eclipse 305757Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00382903057573), received between Apr 18, 2018 and Sep 8, 2026 — classified as 2 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (18 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 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026Leak/Splash; Failure to Deliver

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50674250 ↗
• MalfunctionFeb 9, 2026

  FROM STAFF: DURING THE INFANT RECEIVING THE VITAMIN K INJECTION, WHEN THE NEEDLE WAS REMOVED FROM THE LEFT THIGH IT WAS NOTED TO BE AT ALMOST A 90-DEGREE ANGLE AND WHEN REMOVED RN DID NOT KNOW THE NEEDLE HAD BENT WHILE IN THE MUSCLE AND WHEN REMOVED THE NEEDLE SCRATCHED THE INFANT'S THIGH. THE DEVICE INFORMATION PROVIDED IS FROM A "LIKE" DEVICE. THE DEVICE INVOLVED IN THIS EVENT HAS BEEN DISCARDED BY STAFF.

  Patient problems: Laceration(s)

  MAUDE report 24290614 ↗
• MalfunctionOct 23, 2025Leak/Splash; Leak/Splash

  IN THE FIGURE BELOW, AROUND THE HUB OF THE NEEDLE IS A HORIZONTAL LINE AT THE TOP OF THE YELLOW PART.¿ CONSUMER¿S HUSBAND STATES THIS AREA OFTEN BUILDS UP WITH BESREMI SOLUTION AND THIS SOLUTION LEAKS OUT ONTO ABDOMEN AFTER INJECTION. CONSUMER¿S HUSBAND WOULD LIKE TO KNOW WHY IT IS DESIGNED LIKE THAT. CONSUMER SUGGESTS THAT SMALL HOLES BE PLACED IN THE YELLOW PART SO THE MEDICINE CAN ¿LEAK OUT¿ THROUGH THE HOLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23370874 ↗
• MalfunctionSep 8, 2025Dull, Blunt

  FOR THE PAST SEVERAL WEEKS, MULTIPLE STAFF MEMBERS HAVE NOTICED THAT THE 30G X 1/2" NEEDLES WITH LOT # 4206646 AND EXPIRATION DATE OF 7/31/2029 HAVE BEEN VERY DIFFICULT TO PRESS THROUGH MULTIPLE PATIENT'S SKIN WHILE GIVING ALLERGY SHOTS. THE NEEDLE WILL EITHER BOUNCE OFF THE PATIENT'S SKIN OR IF IT DOES PRESS THROUGH, IT IS NOT SMOOTH AND IT FEELS LIKE YOU HAVE TO FORCE IT THROUGH THE SKIN. WE HAVE NEVER HAD THIS ISSUE BEFORE WITH THESE NEEDLES. THEY USUALLY GLIDE THROUGH SMOOTHLY EVEN IF THERE IS BUILT UP SCAR TISSUE FROM PREVIOUS SHOTS. WE ROTATE THE SITE OF THE SHOTS EACH VISIT. PATIENTS HAVE BEEN REPORTING INCREASED PAIN WHEN THE NEEDLE MANAGES TO GO THROUGH THE SKIN. THIS IS HAPPENING WITH ABOUT 50%-75% OF THE NEEDLES. THERE IS NO WAY FOR US TO TELL BEFOREHAND WHETHER OR NOT THE NEEDLE IS SHARP UNLESS WE BEGIN TO PRESS IT THROUGH THE PATIENT'S SKIN.

  Patient problems: Pain

  MAUDE report 22991185 ↗
• MalfunctionJul 21, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE 30X1/2 SAFETY MECHANISM FAILEDTHE PINK NEEDLE SHIELD WAS STUCK ON THE NEEDLE ITSELF AND THE PATIENT WAS UNABLE TO USE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22557575 ↗
• MalfunctionJul 21, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE 30X1/2 SAFETY MECHANISM FAILED THE PINK NEEDLE SHIELD WAS STUCK ON THE NEEDLE ITSELF AND THE PATIENT WAS UNABLE TO USE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22557538 ↗
• MalfunctionMar 6, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  NO ADDITIONAL INFORMATION.

  Patient problems: Needle Stick/Puncture

  MAUDE report 21537129 ↗
• MalfunctionJan 31, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE 30X1/2 NEEDLE CLOGGED/BLOCKED. IT WAS REPORTED BY CUSTOMER THAT THE INJECTION NEEDLE WAS CLOGGED SO I HAD TO USE A DIFFERENT ONE. RCC RECEIVED A COMPLAINT VIA EMAIL. PATIENT STATES ¿ONE TIME 1 OF THE SYRINGES IN THE KIT DIDN¿T HAVE A PLUNGER IN IT SO I JUST USED THE SAME SYRINGE TO WITHDRAW THE STERILE WATER AND THE EGRIFTA. ANOTHER TIME, THE INJECTION NEEDLE WAS CLOGGED SO I HAD TO USE A DIFFERENT ONE.¿ PATIENT NO LONGER HAS EITHER PRODUCT ON HAND STILL. THE REPORT MENTIONS THAT ONE OF THE BD 1ML SYRINGES IN THE KIT DIDN¿T HAVE A PLUNGER IN IT. UNFORTUNATELY, THE LOT NUMBER OF THE INJECTION KIT OR SYRINGE IS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21287247 ↗
• MalfunctionDec 4, 2024Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE 30X1/2 NEEDLE CLOGGED BLOCKEDWHEN I WAS ABOUT TO INJECT BESREMI, I FOUND THAT THERE WAS RESISTANCE WHEN PUSHING THE NEEDLE, MAKING IT DIFFICULT TO INJECT THE MEDICATION. HOWEVER, AFTER REMOVING THE NEEDLE, I COULD EXPEL AIR, SUGGESTING A POSSIBLE NEEDLE BLOCKAGE ISSUE, PREVENTING SUBCUTANEOUS INJECTION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20847430 ↗
• MalfunctionOct 16, 2024Complete Blockage; Complete Blockage

  MATERIAL# 305757; BATCH# 4029206. IT WAS REPORTED BY CUSTOMER THAT USING THE 30G NEEDLES TODAY AND HE NOTICED THAT ABOUT 7-8 OF THE NEEDLES JAMMED WHILE IN USE ON THE PATIENT. I AM THINKING THIS MAY BE A DEFECTIVE BATCH". "HE WAS USING THE 30G NEEDLES TODAY AND HE NOTICED THAT ABOUT 7-8 OF THE NEEDLES JAMMED WHILE IN USE ON THE PATIENT. I AM THINKING THIS MAY BE A DEFECTIVE BATCH".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20464868 ↗
• MalfunctionSep 25, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BDNEEDLE ECLIPSE 30X1/2 WAS DAMAGED THE PATIENT STATED THAT SHE TRIED TO PUT THE NEEDLE ON THE SYRINGE AND SCREW IT, BUT THE PIECE IN THE SCREW AREA OF THE NEEDLE WAS BROKEN, AND THEN THE MEDICATION WAS LEAKING.SHE STATED THAT SHE TRIED TO UNSCREW IT, BUT THE MEDICATION KEPT ON LEAKING UNTIL THERE WAS NO MEDICATION LEFT IN THE SYRINGE. THE PATIENT STATED THAT SHE COULDN¿T IDENTIFY WHERE THE DAMAGE PART WAS, ALL SHE REMEMBERED IS THAT THE DAMAGE WAS AT THE CONNECTOR PART OF THE SYRINGE. THE SYRINGE THAT PAIRS WITH THIS NEEDLE IS THE BD SYRINGE BARREL, HYOAK SCF1MLL RF PRTC7025/65, BD PART NO. 47204710.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20304584 ↗
• MalfunctionAug 26, 2024Complete Blockage; Complete Blockage

  PATIENT WANT TO INJECT HIS BESREMI THE NEEDLE MALFUNCTIONED AND IT WOULDN' T INJECT. HE DISCARDED THAT ONE AND OPEN A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20064591 ↗
• MalfunctionJan 9, 2024Blocked Connection; Blocked Connection

  MATERIAL#: 305757. BATCH#: 2341255. IT WAS REPORTED BY CUSTOMER THAT LIQUID WAS UNABLE TO INJECT FROM THE ECLIPSE NEEDLE- RESISTANCE WHEN TRYING TO PUSH MEDICINE. VERBATIM: LIQUID WAS UNABLE TO INJECT FROM THE ECLIPSE NEEDLE- RESISTANCE WHEN TRYING TO PUSH MEDICINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18479227 ↗
• MalfunctionNov 30, 2023Complete Blockage; Complete Blockage

  MATERIALS#: 305757 BATCH#: 2341255. IT WAS REPORTED BY THE CUSTOMER THAT INSTANT BLOCKAGE WHEN TRYING TO ADMINISTER MEDICINE THROUGH NEEDLE. VERBATIM: INSTANT BLOCKAGE WHEN TRYING TO ADMINISTER MEDICINE THROUGH NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18236968 ↗
• MalfunctionMay 19, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD ECLIPSE¿ NEEDLES WERE BLOCKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NO HARM. WE HAD ANOTHER NEEDLE WITH THE SAME ISSUE AGAIN TODAY, SAME LOT NUMBER, NO HARM AGAIN SPOKE WITH OFFICE MANAGER SAME ISSUE OF FLUID NOT COMING OUT OF NEEDLES, CUSTOMER HAS SENT IN FOR EVALUATON WITH OTHER COMPLAINT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16964009 ↗
• MalfunctionMay 12, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT 2 BD ECLIPSE¿ NEEDLE WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: WE HAVE TWO MORE NEEDLES TODAY THAT WE WERE ATTEMPTING TO USE ON A PATIENT TO NUMB LOCALLY WITH LIDOCAINE WHERE NOTHING WOULD COME OUT OF THEM AS IF THERE WAS NO HOLE/OPENING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16919335 ↗
• MalfunctionMay 11, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED WHILE USING BD ECLIPSE¿ NEEDLE THE NEEDLE WAS CLOGGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE JUST HAD ANOTHER ONE TODAY THAT WE WERE ATTEMPTING TO LOCALLY NUMB A PATIENT WITH LIDOCAINE WHERE NOTHING WOULD COME OUT AS IF THERE WAS NO HOLE OR OPENING. ARE YOU ABLE TO PROVIDE THE INCIDENT DATE? ON (B)(6) 2023. WHAT IS THE PATIENT OUTCOME? ARE THERE ANY ADVERSE EVENTS/SERIOUS INJURIES? NO ADVERSE EVENTS, JUST CHANGED THE NEEDLE OUT WHEN WE WENT TO INJECT AND NOTHING CAME OUT WAS THERE A DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THE EVENT? THE ONLY DELAY WAS BECAUSE WE HAD TO CHANGE THE NEEDLE OUT UNTIL WE FOUND ONE THAT WAS WORKING. WERE YOU ABLE TO DRAW UP SOLUTION AND THEN UNABLE TO EXPEL? SEPARATE NEEDLES ARE USED TO DRAW UP SOLUTION. IS THERE ANY VISIBLE BLOCKAGE? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16916928 ↗
• MalfunctionMay 11, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED WHILE USING BD ECLIPSE¿ NEEDLE THE NEEDLE WAS CLOGGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE TWO MORE NEEDLES TODAY THAT WE WERE ATTEMPTING TO USE ON A PATIENT TO NUMB LOCALLY WITH LIDOCAINE WHERE NOTHING WOULD COME OUT OF THEM AS IF THERE WAS NO HOLE/OPENING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16915767 ↗
• MalfunctionMay 11, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD ECLIPSE¿ NEEDLE WAS BLOCKED WHEN ATTEMPTING TO INJECT LIDOCAINE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE JUST HAD ANOTHER ONE TODAY THAT WE WERE ATTEMPTING TO LOCALLY NUMB A PATIENT WITH LIDOCAINE WHERE NOTHING WOULD COME OUT AS IF THERE WAS NO HOLE OR OPENING. MA TOSSED IT BEFORE IT COULD BE COLLECTED... NO HARM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16914250 ↗
• MalfunctionMay 4, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT 5 BD ECLIPSE¿ NEEDLES WERE CLOGGED DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE COME ACROSS MANY THAT HAVE NO BORE TO THEM (OPENING). ADDITIONAL INFORMATION RECEIVED ON 13-APRIL-2023. 1. COULD YOU PLEASE CLARIFY IF THE ¿NO BORE TO THEM (OPENING)¿ STATEMENT INDICATES THAT THE NEEDLE TIP HAS NO HOLE? YES. 2. PLEASE DESCRIBE IN DETAIL WHAT WAS THE ISSUE OCCURRED WITH THE DEFECTIVE NEEDLE. THE NEEDLE TIPS HAD NO HOLE. THERE WERE MULTIPLE NEEDLES WITH NO HOLE - 5+. 3. COULD YOU PLEASE ADVISE IF DEFECT WAS FOUND BEFORE USE OR DURING USE OR AFTER USE? DURING USE. 6. WAS THERE ANY PATIENT INVOLVEMENT? ARE THERE ANY ADVERSE EVENTS/SERIOUS INJURIES? 2 PATIENT INVOLVEMENT. NO INJURIES AS WE REPLACED NEEDLE UNTIL WE FOUND ONE THAT WAS WORKING. ADDITIONAL INFORMATION RECEIVED ON 14-APRIL-2023. I CANNOT RECALL WHO THE PATIENTS WERE AS IT HAPPENED IN A SPAN OF TWO DAYS DURING A SURGICAL BIOPSY PROCEDURE FOR THOSE PATIENTS SO OF COURSE WE WERE IN A BIT OF AN EMERGENCY SITUATION TO GET IT FIXED (CHANGING OUT THE NEEDLES UNTIL WE GOT A GOOD ONE). WE WERE USING LOCAL ANES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16869678 ↗
• MalfunctionMay 4, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT 5 BD ECLIPSE¿ NEEDLES WERE CLOGGED DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE COME ACROSS MANY THAT HAVE NO BORE TO THEM (OPENING)... ADDITIONAL INFORMATION RECEIVED ON 13-APRIL-2023. 1. COULD YOU PLEASE CLARIFY IF THE ¿NO BORE TO THEM (OPENING)¿ STATEMENT INDICATES THAT THE NEEDLE TIP HAS NO HOLE? YES 2. PLEASE DESCRIBE IN DETAIL WHAT WAS THE ISSUE OCCURRED WITH THE DEFECTIVE NEEDLE. THE NEEDLE TIPS HAD NO HOLE. THERE WERE MULTIPLE NEEDLES WITH NO HOLE - 5+. 3. COULD YOU PLEASE ADVISE IF DEFECT WAS FOUND BEFORE USE OR DURING USE OR AFTER USE? DURING USE.. 6. WAS THERE ANY PATIENT INVOLVEMENT? ARE THERE ANY ADVERSE EVENTS/SERIOUS INJURIES? 2 PATIENT INVOLVEMENT. NO INJURIES AS WE REPLACED NEEDLE UNTIL WE FOUND ONE THAT WAS WORKING ADDITIONAL INFORMATION RECEIVED ON 14-APRIL-2023. I CANNOT RECALL WHO THE PATIENTS WERE AS IT HAPPENED IN A SPAN OF TWO DAYS DURING A SURGICAL BIOPSY PROCEDURE FOR THOSE PATIENTS SO OF COURSE WE WERE IN A BIT OF AN EMERGENCY SITUATION TO GET IT FIXED (CHANGING OUT THE NEEDLES UNTIL WE GOT A GOOD ONE). WE WERE USING LOCAL ANE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16869674 ↗
• MalfunctionMay 3, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT 8 BD ECLIPSE¿ NEEDLE EXPERIENCED NEEDLE BLOCKED. THIS IS 2 OF 2 RELATED EVENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1 BOX, 5+ INJECTION NEEDLES HAVE NO BORE (OPENING). ADD INFO PROVIDED BY CS ON 4/14; EXACTLY HOW MANY NEEDLES HAD THIS ISSUE FROM THIS LOT? I WOULD SAY APPROXIMATELY 10 NEEDLES WE WENT THROUGH SO FAR THAT WERE FAULTY CAN YOU CONFIRM THERE WAS NOT PATIENT HARM? NO PATIENT HARM. ON WHAT DATE DID THIS OCCUR? (B)(6) 2023 AND (B)(6) 2023. CS RESPONDED ON 4/18. I WOULD SAY APPROXIMATELY 2 ON THE 11TH AND THE REST WERE ON THE 12TH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16858229 ↗
• MalfunctionMay 3, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT 2 BD ECLIPSE¿ NEEDLE EXPERIENCED NEEDLE BLOCKED. THIS IS 1 OF 2 RELATED EVENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1 BOX, 5+ INJECTION NEEDLES HAVE NO BORE (OPENING). ADD INFO PROVIDED BY CS ON 4/14; EXACTLY HOW MANY NEEDLES HAD THIS ISSUE FROM THIS LOT? I WOULD SAY APPROXIMATELY 10 NEEDLES WE WENT THROUGH SO FAR THAT WERE FAULTY. CAN YOU CONFIRM THERE WAS NOT PATIENT HARM? NO PATIENT HARM. ON WHAT DATE DID THIS OCCUR? (B)(6) 2023. CS RESPONDED ON (B)(6). I WOULD SAY APPROXIMATELY 2 ON THE 11TH AND THE REST WERE ON THE 12TH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16858228 ↗
• MalfunctionAug 16, 2022Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE BD ECLIPSE¿ NEEDLE CAME OFF THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE CAME OFF THE SYRINGE AND PIERCED THE CORNEA AND LENS. THE SURGEON REMOVE THE NEEDLE FROM THE PATIENT'S EYE. CORNEA SELF-SEALED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15233266 ↗
• MalfunctionJun 10, 2022Break; Break

  IT WAS REPORTED THAT PRIOR TO USING A 30 G BD ECLIPSE¿ NEEDLE ONLY 1/2 IN. LUER LOCK HUB, THE NEEDLE WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER SAID THE NEEDLE IS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14651797 ↗