BD Eclipse 305764Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00382903057641), received between Jan 3, 2018 and Oct 31, 2025 — classified as 1 injury, 14 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2025Contamination; Contamination

  CUSTOMER STATES THAT DURING DESTRUCTIVE TESTING, 2 VIALS HAVE BEEN IDENTIFIED AS CONTAINING CELLULOSE FIBERS/PARTICULATE MATTER. THESE PMS WERE IDENTIFIED AFTER RECONSTITUTION TESTING WAS PERFORMED USING THE BD 21-GAUGE NEEDLE. RECONSTITUTION TESTING WAS PERFORMED IN A LAF HOOD, WHICH WAS RUN FOR 30 MINUTES AND CLEANED PRIOR TO INTRODUCING TESTING MATERIALS. VISUAL INSPECTION WAS PERFORMED ON THE RECONSTITUTION SOLUTION WHICH RECEIVED PASSING RESULTS. A FLUSH OF THE NEEDLE IS PERFORMED INTO A WASTE CONTAINER PRIOR TO INSERTING THE NEEDLE INTO THE SAMPLE STOPPER. AFTER THE VIALS ARE RECONSTITUTED, VISUAL INSPECTION FOR VISIBLE PARTICULATES IS PERFORMED. IT WAS NOTICED WHILE UNPACKAGING ON THE NEEDLES, MATERIAL FROM THE BACKING OF THE PACKAGING "FLAKING" OFF AND POTENTIALLY ABLE TO BECOME LODGED IN THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23438166 ↗
• MalfunctionMar 10, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE 21X1 RB TW HAD FOREIGN MATTER. IT WAS REPORTED BY CUSTOMER THAT THEY HAD A CONTAMINATED NEEDLE IN A SEALED PACKAGE. THERE IS A BROWN SPOT BY THE GREEN CAP. THERE IS ONLY ONE OCCURRENCE SO FAR. THIS WAS NOT USED ON ANY PATIENT. RCC RECEIVED A COMPLAINT VIA PHONE. CUSTOMER STATES THAT THEY HAVE A CONTAMINATED NEEDLE IN A SEALED PACKAGE. THERE IS A BROWN SPOT BY THE GREEN CAP. THERE IS ONLY ONE OCCURRENCE SO FAR. CUSTOMER HAS PRODUCT TO RETURN IF NEEDED AND A PICTURE IS ATTACHED. THIS WAS NOT USED ON ANY PATIENT. REF NUMBER: 305764. LOT NUMBER: 4147142.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21566574 ↗
• MalfunctionNov 8, 2024Material Protrusion/Extrusion; Material Protrusion/Extrusion

  MATERIAL #:305764, BATCH#:4055237. IT WAS REPORTED BY CUSTOMER THAT THE PHLEBOTOMIST WAS USING A 21GX1 ECLIPSE NEEDLE ON A HUB TO DRAW BLOOD. WHEN SHE WENT TO SAFETY THE DEVICE ON HER HAND, THE SAFETY CAME OFF CAUSING AN ACCIDENTAL NEEDLE STICK IN THE PHLEBOTOMIST. VERBATIM: RCC RECEIVED A COMPLAINT VIA COMMUNITY. PIR ATTACHED. OUR PHLEBOTOMIST WAS USING A 21GX1 ECLIPSE NEEDLE ON A HUB TO DRAW BLOOD. WHEN SHE WENT TO SAFETY THE DEVICE ON HER HAND, THE SAFETY CAME OFF CAUSING AN ACCIDENTAL NEEDLE STICK IN THE PHLEBOTOMIST.

  Patient problems: Needle Stick/Puncture

  MAUDE report 20637860 ↗
• MalfunctionJul 2, 2024Complete Blockage; Complete Blockage

  MATERIAL # 305764; BATCH # 3237715. IT WAS REPORTED BY CUSTOMER THAT THE NEEDLE WILL NOT ALLOW TO PUSH OUT ANY AIR OR MEDICATION. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. GOOD MORNING, IT HAS COME TO MY ATTENTION RECENTLY THAT IN VARIOUS BOXES OF PURCHASED BD ECLIPSE NEEDLES THROUGH AND A HAVE BEEN SOMEWHAT FAULTY. ONCE THE NEEDLES ARE MOVED TO SYRINGES WITH OR WITHOUT MEDICATION IN THEM, THE NEEDLE WILL NOT ALLOW TO PUSH OUT ANY AIR OR MEDICATION, AND THE NEEDLE HAS TO BE CHANGED WHICH IS A WASTE OF RESOURCES. PRODUCT INFORMATION IS BELOW TAKEN FROM ANDA. JUST CURIOUS IF ANY OTHER MEDICAL FACILITIES HAVE HAD THIS ISSUE AS WELL OR IF THERE IS A WAY TO RESOLVE THIS. NEEDLE 21GX1. BRAND EQUIVALENT: NEEDLE 21GX1. NDC: (B)(4) UPC: 0130382903057642. ITEM: (B)(6). SIZE: (B)(4). FORM: MEDICAL/SURGICAL SUPPLY ITEM. MANUFACTURER: BD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19659369 ↗
• MalfunctionJun 14, 2024Packaging Problem; Packaging Problem

  1BX (100EA) FOUND DAMAGED UPON CHECKING OF STOCKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19539986 ↗
• MalfunctionAug 18, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE BD ECLIPSE¿ NEEDLE UNIT PACKAGE WAS TORN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FOR THE 2 BOXES, THE QUANTITY IS ONLY 99PCS EACH. THERE IS A SHORTAGE OF 1 ITEM IN EACH BOX; THE OTHER BOX CONTAINS 1 DEFECTIVE (TEAR). SHORT - 2 BOXES (100EA) - LOT 3011955 . DAMAGE - 1 BOX (100EA) - LOT 3011955.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17579932 ↗
• MalfunctionMay 5, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT ONE BD ECLIPSE¿ NEEDLE EACH FROM LOTS 1274627 AND 1238901 HAD BLACK FOREIGN MATTER ON THEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE WERE BLACK SPECS IN THE NEEDLES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14293320 ↗
• InjuryDec 16, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT A NEEDLE ECLIPSE 21X1 RB TW CAUSED AN ALLERGIC REACTION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED AFTER INJECTION THE PT DEVELOPED REDNESS, PAIN AND SWELLING OF THE LEFT THIGH. HE HAD LEFT THIGH ABSCESS INCISION AND DRAINAGE BY THE NEXT DAY. IT HAD GOTTEN WORSE, SO HE WAS ADMITTED FOR IV ANTIBIOTICS AND PACKING OF THE WOUND VERBATIM: PER CUSTOMER RESPONSE, ON THE E-MAIL: 11/19/2020. THE NEEDLE IS ONE THAT CAME IN A BOX OF BICILLIN. WE¿D NEVER SEEN A REACTION LIKE THIS AFTER GIVING THIS MEDICATION SO WE FELT IT WAS WORTH REPORTING. I¿M NOT SURE WHAT CAUSED THIS CHILD¿S ABSCESS, IF IT WAS THE NEEDLE, THE MEDICATION, THE FACT THAT HE VOMITED ON THE SITE AFTER THE INJECTION WAS GIVEN OR WHAT WAS THE CAUSE. THE NEEDLE WAS A BD ECLIPSE 21 G 1 IN, LOT # 7176188, EXP. 06/30/2022. ON (B)(6) 2020, PT RECEIVED A BICILLIN INJECTION IN HIS LEFT THIGH FOR TX OF STREP PHARYNGITIS. IMMEDIATELY AFTER RECEIVING THE INJECTION, HE VOMITED IN HIS LAP AND ON HIS LEGS IN THE AREA WHERE HE HAD RECEIVED THE INJECTION. WITHIN A DAY OR TWO OF THE INJECTION HE DEVELOPED REDNESS, PAIN AND SWELLING OF THE LEFT THIGH, AT/NEAR THE INJECTION SITE BY (B)(6

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 11023784 ↗
• MalfunctionFeb 12, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT NEEDLE ECLIPSE 21X1 RB TW LEAKED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305764, BATCH NO.: UNKNOWN. IT WAS REPORTED THAT AS THE SAFETY DEVICE IS ENGAGED, BLOOD WILL EITHER DRIBBLE OUT OF THE NEEDLE TIP OR ON SOME OCCASIONS, IT WILL ALMOST SPLASH OUT A DROP. VERBATIM: THE OTHER DAY IT WAS BROUGHT TO MY ATTENTION THAT WE HAVE HAD SOME ISSUES WITH THE USE OF THE ECLIPSE SAFETY NEEDLES. NO ONE HAS EVER SAID ANYTHING UNTIL NOW AND IT MAY BE A USER ERROR ISSUE, BUT I WANTED TO FOLLOW-UP ON IT. IT SEEMS THAT AS THE SAFETY DEVICE IS ENGAGED, THAT IT IS NOT UNCOMMON THAT BLOOD WILL EITHER DRIBBLE OUT OF THE NEEDLE TIP OR ON SOME OCCASIONS IT WILL ALMOST SPLASH OUT A DROP. WE HAVE NOT HAD ANY SITUATIONS IN WHICH SOMEONE HAS BEEN HARMED OR EVEN EXPOSED. I AM UNDERSTANDING THAT THIS HAS BEEN HAPPENING FOR A LONG TIME, SO IT LEADS ME TO BELIEVE IT'S NOT SPECIFIC TO A LOT NUMBER, BUT MOST LIKELY IS RELATED TO THE GUIDELINES WARNING OF EXCESS BLOOD IN THE NEEDLE.

  Patient problems: Injury

  MAUDE report 9701217 ↗
• MalfunctionJan 30, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT NEEDLE ECLIPSE 21X1 RB TW HAD FOREIGN MATTER ON THE SHAFT OF THE NEEDLE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305764 BATCH NO.: 9084948 IT WAS REPORTED THAT THE SHAFT OF THE NEEDLE WAS COVERED IN A WHITE PLASTIC-LIKE MATERIAL. VERBATIM: WE RECENTLY HAD AN ISSUE WITH ONE OF OUR ECLIPSE NEEDLES. THE SHAFT OF THE NEEDLE WAS COVERED IN A WHITE PLASTIC-LIKE MATERIAL. UNFORTUNATELY, THE PHLEBOTOMIST HAD NOT PERFORMED A SAFETY CHECK TO INSPECT THE NEEDLE BEFORE USE. SHE INSERTED THE BEVEL OF THE NEEDLE, NOTICED THE ISSUE, THEN REMOVED THE NEEDLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9648158 ↗
• MalfunctionJul 17, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT PACKAGE DAMAGE OCCURRED BEFORE USE WITH A NEEDLE ECLIPSE 21X1 RB TW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "DURING THE PACKAGING ON (B)(6) 2019, NEEDLE 21 GAUGE I" BD ECLIPSE (VENDOR LOT 849969) WAS NOTED TO HAVE MULTIPLE PUNCTURES OF THE POUCH FOR 2 SLEEVES. THE DEFECT IS SUCH THAT IT QUESTIONS THE STERILITY OF THE PRODUCT RECEIVED FROM BD." 2 OCCURRENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8798392 ↗
• MalfunctionApr 23, 2019Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER "BICILLIN LA" WAS ADMINISTERED WITH THE NEEDLE ECLIPSE 21X1 RB TW, THE SAFETY SHIELD BROKE OFF WHEN ATTEMPTING TO COVER THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SITE IS IN RECEIPT OF A MARKED PRODUCT COMPLAINT IDENTIFYING A NEEDLE THAT WAS SUPPLIED WAS DULL. THE USER REPORTED THAT THE NEEDLE WAS MORE DIFFICULT TO PUSH THROUGH. THE CUSTOMER STATED THAT THE BICILLIN LA WAS ADMINISTERED SUCCESSFULLY AND NO COMPLICATIONS OCCURRED. THE CUSTOMER ALSO STATED THAT THE SAFETY SHIELD BROKE OFF WHEN CLOSING. BD ECLIPSE NEEDLE 21 GAUGE 1" (VENDOR LOT: 7176188) WERE USED TO PACKAGE BICILLIN LA 1ML BATCH W0783.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8539880 ↗
• MalfunctionNov 21, 2018No Fail-Safe Mechanism

  IT WAS REPORTED THAT A BD¿ NEEDLE ECLIPSE 21X1 RB TW HAD A FAILURE SAFETY SHIELD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8096562 ↗
• MalfunctionMay 8, 2018Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATERIAL WAS FOUND IN THE ¿NEEDLE CAPSULE¿ OF A BD ECLIPSE¿ HINGED SAFETY NEEDLE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7496482 ↗
• MalfunctionJan 3, 2018Unsealed Device Packaging

  IT WAS REPORTED BEFORE USE OF THE BD ECLIPSE¿ NEEDLE DURING THE INCOMING INSPECTION OF BD ECLIPSE NEEDLE (SUPPLIER LOT NUMBER 7176189) THE PFIZER ROCHESTER SITE FOUND AN UNSEALED NEEDLE PACKET. PER THE ROCHESTER INCOMING INSPECTION THIS IS CONSIDERED A CRITICAL DEFECT AND THE INSPECTION LOT IS REJECTED. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7160927 ↗