BD EclipseTM Needle 25G x 1"TW 305837Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00382903058372), received between Nov 22, 2023 and Jun 13, 2024 — classified as 3 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Defective Component” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K161170); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 2024Complete Blockage; Complete Blockage

  MATERIALS #: 305837, BATCH #: 2125855. IT WAS REPORTED THAT THE BD NEEDLE ECLIPSE 25X1 RB WAS CLOGGED/BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE 1ST NEEDLE WAS DISCOVERED ON 5/16/24 AND THE SAFETY ZONE PORTAL INCIDENT (B)(4) WAS CREATED: DETAILS: ¿PATIENT WAS SCHEDULED FOR HEPATITIS A VACCINATION. WRITER ATTEMPTED TO ADMINISTER HEPATITIS A VACCINE IN LEFT DELTOID BUT PLUNGER WOULD NOT DEPRESS. WRITER REMOVED NEEDLE FROM PATIENT'S DELTOID AND ACTIVATED SAFETY FEATURE. WRITER APOLOGIZED TO PATIENT AND ASKED IF PATIENT STILL WANTED TO RECEIVE HEPATITIS A VACCINATION, PATIENT WAS AGREEABLE. NEW VACCINE HEPATITIS A VACCINATION ADMINISTERED IN LEFT DELTOID WITH SUCCESS. AFTER PATIENT LEFT WRITER FURTHER EXAMINED VACCINE AND NEEDLE, THE 25 GAUGE 1 INCH NEEDLE DID NOT HAVE A HOLE IN IT. WRITER NOTIFIED CLINIC COORDINATER (B)(6).¿ WE DIDN¿T FILE A COMPLAINT WITH BD BECAUSE WE DIDN¿T HAVE THE SPECIFIC NEEDLE PACKAGING WITH LOT NUMBER. WE SUSPECTED IT WAS FROM BD ECLIPSE LOT 2125855. ADDITIONAL INFORMATION PROVIDED: 1. HOW WAS THE PATIENT OUTCOME? ARE THERE ANY CLINICAL SIGNS, HEALTH CONSEQUENCES OR IMPACT? PT HAD TO BE POKED TWICE. 2. ANY ADVERSE EVENT OR SE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19534312 ↗
• InjuryJun 1, 2024Break; Break

  MATERIAL: 305837 LOT:2111820. IT WAS REPORTED THAT THE BD NEEDLE ECLIPSE 25X1 RB SAFETY MECHANISM FAILED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. PRODUCT COMPLAINT - CUSTOMER CALLED TO REPORT THAT WHILE SHE WAS VACCINATING A PT. THE NEEDLE BROKE AWAY FROM THE SYRINGE AND GOT STUCK IN A PATIENT, SHE EXPERIENCED A NEEDLE STICK INJURY REF: (B)(4) LOT 2111820, DOE (B)(6) 2024 , THE MEDICATION SPILLED EVERY WHERE AND UNSURE IF THE PT RECEIVED FULL DOSAGE OF THE VACCINATION. SHE COLLECTED BLOOD SAMPLE FROM THE PATIENT TO TEST FOR ANY COMMUNICABLE DISEASE. SHE ALSO ADVISED THAT ANOTHER NURSE HAS EXPERIENCED SUCH INCIDENT WHERE THE NEEDLE DETACHED FROM THE SYRINGE CAUSING A NEEDLE STICK INJURY AS WELL AND SHE THINKS IT IS FROM THE SAME LOT NUMBER. SHE FURTHER NARRATED HOW THIS HAS HAPPENED IN THE PAST, LAST YEAR AND SAME INCIDENT ESPECIALLY WITH THIS VERY TYPE OF NEEDLE BUT IT WAS NOT REPORTED TO BD, ONLY TO THEIR SAFETY DEPARTMENT. ADDITIONAL INFORMATION PROVIDED ON 5/8/2024: 1. I DO NOT HAVE ANY PHOTOS TO PROVIDE AS I DISPOSED OF THE NEEDLE IN THE SHARP'S CONTAINER. 2. THE NEEDLE WAS CONTAMINATED WITH CLI

  Patient problems: Needle Stick/Puncture

  MAUDE report 19443301 ↗
• InjuryJun 1, 2024Defective Component; Defective Component

  IMDRF CODES MUST BE UPDATED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 19443293 ↗
• MalfunctionMar 19, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD NEEDLE ECLIPSE 25X1 RB HAD FOREIGN MATTER, THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PER CUSTOMER THE COMPROMISED NEEDLES WE ARE FINDING HAVE A WHITE WAXY OR PLASTIC SUBSTANCE ON THE NEEDLE. SEE PHOTO." ADDITIONAL INFORMATION PROVIDED ON 02/29/2024: "INCIDENT OCCURRED FRIDAY FEB. 9, 2024. A MEDICAL ASSISTANT NOTICED THE COMPROMISED NEEDLE WHILE PREPARING TO INJECT THE PATIENT. NO PATIENT WAS HARMED. I NO LONGER HAVE THE SAMPLE WE FOUND, JUST THE PICTURE THAT WAS TAKEN." ITEM#305837. LOT#2046318.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18937778 ↗
• MalfunctionMar 19, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THE BD NEEDLE ECLIPSE 25X1 RB SAFETY SHIELD BROKE OFF.THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER:"SAFETY PART CAME OFF""TWO INSTANCES WHERE THE SAFETY PART CAME OFF AND THIS LAST TIME EMPLOYEE WAS STUCK BECAUSE THE SAFETY GUARD CAME OFF.".MATERIAL #: 305837 BATCH#: 2046337, 2077251, 2091800.I HAVE ATTACHED INFORMATION ON THE PRODUCT I RECEIVED FOR THIS ADVERSE EVENT COMPLAINT. I WOULD LIKE TO REQUEST A RA# AND THE RETURN ADDRESS, SO I CAN RETURN THE PRODUCT FOR EVALUATION AND CREDIT. FOR THE FREIGHT CHARGES, WOULD YOU BE ABLE TO EMAIL ME A LABEL OR LET US KNOW YOUR SHIPPING ACCOUNT NUMBER? THE ADDRESS HERE IS (B)(6).IF YOU HAVE ANY QUESTIONS PLEASE LET ME KNOW.(B)(6).(B)(6).ITEM#305837.LOT#2046337,2077251, 2091800.

  Patient problems: Needle Stick/Puncture

  MAUDE report 18937709 ↗
• MalfunctionMar 19, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THE BD NEEDLE ECLIPSE 25X1 RB SAFETY SHIELD BROKE OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SAFETY PART CAME OFF" "TWO INSTANCES WHERE THE SAFETY PART CAME OFF AND THIS LAST TIME EMPLOYEE WAS STUCK BECAUSE THE SAFETY GUARD CAME OFF." MATERIAL #: 305837 BATCH#: 2046337, 2077251, 2091800. I HAVE ATTACHED INFORMATION ON THE PRODUCT I RECEIVED FOR THIS ADVERSE EVENT COMPLAINT. I WOULD LIKE TO REQUEST A RA# AND THE RETURN ADDRESS, SO I CAN RETURN THE PRODUCT FOR EVALUATION AND CREDIT. FOR THE FREIGHT CHARGES, WOULD YOU BE ABLE TO EMAIL ME A LABEL OR LET US KNOW YOUR SHIPPING ACCOUNT NUMBER? THE ADDRESS HERE IS (B)(6). IF YOU HAVE ANY QUESTIONS PLEASE LET ME KNOW. (B)(6). ITEM#305837. LOT#2046337,2077251, 2091800.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18937708 ↗
• MalfunctionMar 19, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THE BD NEEDLE ECLIPSE 25X1 RB SAFETY SHIELD BROKE OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SAFETY PART CAME OFF". "TWO INSTANCES WHERE THE SAFETY PART CAME OFF AND THIS LAST TIME EMPLOYEE WAS STUCK BECAUSE THE SAFETY GUARD CAME OFF." MATERIAL #: 305837, BATCH#: 2046337, 2077251, 2091800. I HAVE ATTACHED INFORMATION ON THE PRODUCT I RECEIVED FOR THIS ADVERSE EVENT COMPLAINT. I WOULD LIKE TO REQUEST A RA# AND THE RETURN ADDRESS, SO I CAN RETURN THE PRODUCT FOR EVALUATION AND CREDIT. FOR THE FREIGHT CHARGES, WOULD YOU BE ABLE TO EMAIL ME A LABEL OR LET US KNOW YOUR SHIPPING ACCOUNT NUMBER? THE ADDRESS HERE IS (B)(6). IF YOU HAVE ANY QUESTIONS PLEASE LET ME KNOW. (B)(6), ITEM#305837. LOT#2046337,2077251, 2091800.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18937706 ↗
• MalfunctionMar 6, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT THE BD NEEDLE ECLIPSE 25X1 RB SAFETY MECHANISM FAILED (ECLIPSE). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TWO INSTANCES WHERE THE SAFETY PART CAME OFF AND THIS LAST TIME EMPLOYEE WAS STUCK BECAUSE THE SAFETY GUARD CAME OFF."

  Patient problems: Needle Stick/Puncture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18850225 ↗
• MalfunctionFeb 13, 2024Break; Break

  IT WAS REPORTED THAT THE BD NEEDLE ECLIPSE 25X1 RB NEEDLE WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE TIP OF THE NEEDLE BROKE." INJURIES OR ADVERSE EVENT: NO. MEDLINE REFERENCE #: (B)(4). ITEM: 305837. QUANTITY AFFECTED: 2 BX. SERIAL/LOT NUMBER: (B)(6). PO #: (B)(4). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES REPORTED ISSUE PER CUSTOMER: CUSTOMER MICHAELA EMAILED TO REPORT THE TIP OF THE NEEDLE BROKE. PICTURES ATTACHED. REPLACEMENT REQUESTED. LOT 2305839. CUSTOMER DISPOSITION REQUEST: REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18700419 ↗
• MalfunctionFeb 8, 2024Complete Blockage; Complete Blockage

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18672789 ↗
• MalfunctionDec 6, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT THE BD NEEDLE ECLIPSE 25X1 RB SAFETY MECHANISM FAILED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THEY AREN'T GLIDING LIKE THEY USED TO. YOU'LL PUSH IT IN, AND IT STOPS, THEN YOU HAVE TO REALLY APPLY PRESSURE TO GET IT TO GO FURTHER IN. THEY DO HAVE NEEDLES TO SEND IN FOR INVESTIGATION IF NEEDED."

  Patient problems: Insufficient Information

  MAUDE report 18277886 ↗
• MalfunctionNov 29, 2023Leak/Splash; Leak/Splash

  MAT#: 305837, BATCH#:2077214. OT WAS REPORTED BY THE CUSTOMER THAT CUSTOMER ADMINISTERED VACCINE 02NOV2023, AND THEY DON'T KNOW WHERE POINT OF FAILURE IS, BUT THE VACCINE LEAKED OUT OF THE SYRINGE. VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. COSTCO PHARMACY CA STORE 1015 REF (B)(4), LOT 2077214, BD ECLIPSE¿ NEEDLE 25 G X 1 IN. ADMINISTERED VACCINE 02NOV2023, AND THEY DON'T KNOW WHERE POINT OF FAILURE IS, BUT THE VACCINE LEAKED OUT OF THE SYRINGE. SYRINGE WAS DISPOSED OF, NO SAMPLE TO SEND IN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18229566 ↗
• InjuryNov 22, 2023Defective Component; Defective Component

  SAMPLES RECEIVED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 18190880 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K161170. One submission often covers many models, so check the product and lot details in each record.

• Z-1440-2017 · Dec 20, 2016 · Terminated
  Eclipse Hypodermic Needle