BD Eclipse 305758Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00382903057580), received between Feb 5, 2020 and Sep 16, 2026 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (5 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.

• MalfunctionSep 16, 2026Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50790362 ↗
• MalfunctionFeb 23, 2026Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24415120 ↗
• MalfunctionDec 5, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE 27X1/2 LEAKED; IT WAS REPORTED BY CUSTOMER THAT VELCADE LEAKED OUT OF THE NEEDLE WHERE THE NEEDLE CONNECTS TO THE PLASTIC BASE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL OF UNITS THAT EXPERIENCED THE PROBLEM 1 DATE OF OCCURRENCE 10/15/25. IF APPLICABLE IDENTIFY THE DRUG, INFUSION RATE, PRIMARY OR SECONDARY INFUSION. VELCADE SUBCUTANEOUS GENERAL DESCRIPTION OF COMPLAINT USING A TEXIUM 3 ML SYRINGE WITH A BD ECLIPSE 27G X ½¿ NEEDLE. WHEN GIVING SUBCUTANEOUS INJECTION OF VELCADE ¿ VELCADE LEAKED OUT OF THE NEEDLE WHERE THE NEEDLE CONNECTS TO THE PLASTIC BASE (NOT A LEAK AT THE LEUR CONNECTION) IS THERE SAMPLE AVAILABLE, PLEASE RETAIN. YES, I HAVE THE NEEDLE AND PACKAGE. PATIENT INJURY Y/N, DETAILS OF INJURY. NO. WAS MEDICAL INTERVENTION NECESSARY? Y/N, DESCRIBE; NO, PATIENT RECEIVED MOST OF THE DOSE OF DRUG. WAS THERAPY INTERRUPTED? Y/N EXPLAIN; NO. *IF PRODUCT HAS CHEMOTHERAPY OR HAZARDOUS CHEMICALS, PLEASE SEE SPECIAL INSTRUCTIONS. TRACE CHEMOTHERAPY IN AND ON SYRINGE AND NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23729040 ↗
• MalfunctionJan 6, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  MATERIAL: 305758 BATCH#: 3142041 IT WAS REPORTED BY THE CUSTOMER THAT FOREIGN PARTICULATE MATTER WITH THE NEEDLE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. PCI PO #564938 BD ITEM #305758 ¿ 27G X ½¿ ECLIPSE NEEDLE BD LOT #3142041 ISSUE: PCI RECEIVED A CUSTOMER COMPLAINT REPORTING FOREIGN PARTICULATE MATTER WITH THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21079952 ↗
• MalfunctionSep 25, 2024Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE 27X1/2 SAFETY MECHANISM FAILED. IT WAS REPORTED BY CUSTOMER THAT ONE OF MY STAFF HAD A NEEDLE STICK INJURY THIS MORNING - AS THE NEEDLE WAS FAULTY AND DETACHED FROM SAFETY MECHANISM, EXPLAINED SAFETY DID NOT STOP AT NEEDLE AND SAFETY BENT INTO NEEDLE CAUSING NEEDLESTICK INJURY. VERBATIM: COMPLAINT RECEIVED VIA EMAIL(S) ATTACHED. RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. CHC COMPLAINT REFERENCE #: (B)(4). CUSTOMER (HOSPITAL) NAME: (B)(6) HOSPITAL. CUSTOMER ADDRESS: (B)(6). CONTACT NAME: (B)(6). PHONE: (B)(6). FAX: (B)(6). E-MAIL: (B)(6). CORRESPONDENCE LANGUAGE: ENGLISH. CAT# OF PRODUCT BEING COMPLAINED: BD305758. DESCRIPTION OF PRODUCT: NEEDLE ECLIPSE 27GX1/2 IN F/LL SYR 100EA/PK 12PK/CA. LOT OR S/N: (B)(6). COMPLAINT CATEGORY: FAIL TO FUNCTION / DEFECTIVE. REPORTABLE: NO. INCIDENT DATE: (B)(6) 2024. DETAILS OF COMPLAINT (REPORTED ISSUE): ONE OF MY STAFF HAD A NEEDLE STICK INJURY THIS MORNING - AS THE NEEDLE WAS FAULTY AND DETACHED FROM SAFETY MECHANISM, EXPLAINED SAFETY DID NOT STOP AT NEEDLE AND SAFETY BENT INTO NEEDLE CAUSING NEEDLESTICK INJURY. THE STAFF MEMBER HAS BEEN TO OCCUPATIONAL HEALTH AND COMPLETED AN INCIDENT FORM CUS

  Patient problems: Needle Stick/Puncture

  MAUDE report 20305812 ↗
• MalfunctionJun 17, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE 27X1/2 LABEL CONTENT MISSING IT WAS REPORTED BY THE CUSTOMER THAT THE LOT VARIABLE DATA ON NEEDLE ECLIPSE BLISTER IS MISSING, AS REQUIRED PER AMGEN REQUIREMENTS. VERBATIM: ON (B)(6) 2024: DURING INCOMING INSPECTION AT IQA OFFICE OF BD NEEDLE ECLIPSE BATCH 0010759435, SR. ASSOCIATE QA OBSERVED THAT THE LOT VARIABLE DATA ON NEEDLE ECLIPSE BLISTER IS MISSING, AS REQUIRED PER AMGEN REQUIREMENTS. - 5 OUT OF 315 SAMPLED NEEDLE ECLIPSE UNITS WERE MISSING THE LOT VARIABLE DATA THUS NOT ACCORDING TO SPECIFICATION REQUIREMENTS. REFER TO ATTACHMENT "TR# 586110, MISSING LOT VARIABLE DATA". THE ACCEPTANCE AND REJECT CRITERIA FOR THE ASSIGNED INSPECTION PROFILE: NORMAL, AQL (0.15) FOR THE APPEARANCE WAS 1 AND 2 RESPECTIVELY. BECAUSE THE CRITERIA WERE NOT MET, THE COMPLETE BATCH FAILED QUALITY INSPECTION. IMPACTED BATCH DATA VENDOR BATCH# 4029205. AMGEN BATCH# 0010759435. QUANTITY: 30000 EA. EXPECTED SITUATION: THE LOT VARIABLE DATA OF THE BD NEEDLE ECLIPSE UNITS IS EXPECTED TO BE PRESENT ON EACH NEEDLE ECLIPSE BLISTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19548468 ↗
• MalfunctionSep 13, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED WHILE USING BD ECLIPSE¿ NEEDLE THE LABEL WAS MISSING INFORMATION. THIS OCCURRED ON 64800 PIECES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6) HAS INFORMED ME THAT DURING THE APPEARANCE INSPECTION OF THE ECLIPSE NEEDLES BATCH 0010716410, VENDOR LOT 3083420 RECEIVED LAST WEEK. IT WAS NOTIFIED THAT THE TITLE ON THE BLISTER WAS PRINTED ON THE PERFORATION. WHICH MEANS THAT WHEN THE PACKS GET SEPARATED, SOME OF THE TEXT IS MISSING/UNREADABLE. IT WAS FOUND AROUND 20 PACKS FROM ONE BOX WITH THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17738524 ↗
• MalfunctionJun 9, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING BD ECLIPSE¿ NEEDLE LEAKAGE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AMGEN RECEIVED NOTIFICATION ON 24-APR-2023 FROM A PHARMACIST OF A COMPLAINT FOR NPLATE VIAL - LYOPHILIZED INVOLVING 1 UNIT FROM LOT/BATCH 1151647F. THE DATE OF THE EVENT WAS NOT PROVIDED. THE PHARMACIST REPORTED THE FOLLOWING EVENT: THE PHARMACIST REPORTED THAT THE PRODUCT LEAKED ON THE TABLE DURING THE ATTEMPTED INJECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17101169 ↗
• MalfunctionDec 9, 2021Break; Break

  IT WAS REPORTED THAT THE BD ECLIPSE¿ NEEDLES SAFETY MECHANISM DETACHED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PHARMACY CALLING IN REGARDS TO PATIENTS MOM REPORTING EQUIPMENT FAILURE ON 27G NEEDLE SAFETY DEVICE HAS BEEN SNAPPING OFF."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12972026 ↗
• MalfunctionAug 17, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE BD ECLIPSE¿ NEEDLE LABELING HAD NO EU IMPORTER INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NO EU IMPORTER IS PRESENT ON THE LABELING".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12334810 ↗
• MalfunctionSep 26, 2020Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD ECLIPSE¿ NEEDLES EXPERIENCED SAFETY MECHANISM FAILURE AND A SAFETY MECHANISM THAT WOULD NOT ENGAGE. IT HAS NOT BEEN SPECIFIED WHETHER THE PRODUCT DEFECTS WERE NOTED PRIOR TO, DURING, OR AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 305758 BATCH NO. 9081631. COMPLAINT 2 OF 2: THIS RECORD REFLECTS THE #27 NEEDLE. OUR L&D DEPARTMENT HAS HAD MULTIPLE ISSUES WITH THE PRODUCT #'S AND LOT #'S BELOW; WE CANNOT USE THEM. THEY ARE NOT ENGAGING PROPERLY; THEY GET STUCK AT AN ANGLE. OUR RISK MANAGER WILL BE ENTERING THIS INTO MEDSUN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10590934 ↗
• MalfunctionAug 17, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD ECLIPSE¿ NEEDLES EXPERIENCED THE NEEDLE AND SYRINGE SEPARATING/SPINNING OUT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305758 BATCH NO: 9361589. IT WAS REPORTED THAT WHEN RN IS ADMINISTERING AN IMMUNOTHERAPY INJECTION, THE NEEDLE REMAINS IN THE PATIENT AND THE PATIENT DOES NOT RECEIVE THE APPROPRIATE DOSE ORDERED. AFTER DISCUSSING THIS WITH MANAGEMENT, WE FELT THAT IT WASN'T NECESSARY TO SEND SAMPLES IN FOR INVESTIGATION. AS PREVIOUSLY MENTIONED, THE MORE WE LOOKED INTO THIS ISSUE, WE REALIZED WE COULD HAVE BEEN USING THE NEEDLES WITH A MORE COMPATIBLE LUER LOCK STYLE SYRINGE. MOVING FORWARD WE WOULD LIKE TO IMPLEMENT THIS, AND EXPECT THAT USING THE LUER LOCK SYRINGE WOULD PREVENT ANY FURTHER MALFUNCTIONS. I BELIEVE IT HAS OCCURRED APPROXIMATELY 4 TIMES. (B)(6) 2020 FOR TWO DIFFERENT RN'S. WE BELIEVE THIS OCCURRED BECAUSE WE OF THE TYPE OF SYRINGE WE WERE USING. OUR MEDICAL ASSISTANT JUST RECENTLY PLACED AN ORDER FOR THE 1ML TB SYRINGE WITH LUER LOCK, SO HOPEFULLY THIS PROBLEM WILL RESOLVE ITSELF. WE ARE HOPEFUL THAT CHANGING THE SYRINGE WILL PREVENT THIS ISSUE FROM HAPPENING IN THE FUTUR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10418389 ↗
• MalfunctionAug 14, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD ECLIPSE¿ NEEDLES EXPERIENCED THE NEEDLE AND SYRINGE SEPARATING/SPINNING OUT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LOT # 9361589, REF# 305758. ISSUE: WE HAVE RECENTLY HAD A FEW INCIDENTS WHERE AN RN IS ADMINISTERING AN IMMUNOTHERAPY INJECTION AND THE NEEDLE REMAINS IN THE PATIENT, AND DISENGAGES FROM BD 1ML TB SYRINGE. EXCHANGING THE 26G NEEDLE THAT COMES ON THE 1ML TB SYRINGE, WITH THE 27G NEEDLE IS OUR USUAL PRACTICE IN ALLERGY. THERE HASN'T BEEN AN ISSUE WITH THIS UNTIL RECENTLY, AND IT IS CONCERNING, AS THE PATIENT DOES NOT RECEIVE THE APPROPRIATE DOSE OF IMMUNOTHERAPY ORDERED, AND THIS COULD POTENTIALLY HARM THE PATIENT AND/OR CAREGIVER. AFTER A FELLOW RN SPOKE WITH OTHER DEPARTMENTS, APPARENTLY THIS HAS BEEN HAPPENING ON OCCASION. WE ORIGINALLY INTENDED TO CONTACT YOUR COMPANY, TO SEE IF THERE WAS A PROBLEM WITH THIS SPECIFIC LOT # (9361589) OF NEEDLES, TO NOTIFY YOU OF THESE EVENTS, AND INQUIRE IF OTHER CUSTOMERS ARE HAVING SIMILAR ISSUES. UPON FURTHER INVESTIGATION, WE NOTICED THE 27G NEEDLES WE HAVE BEEN PLACING ON THE TB SYRINGES ARE TO BE USED WITH LUER LOCK SYRINGES ONLY. WE BELIEVE TH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10411626 ↗
• MalfunctionMay 27, 2020Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT NEEDLE ECLIPSE 27X1/2 CAUSED A DIRTY NEEDLE STICK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BENT CANNULA. THE NEEDLE IS DISTORTED AFTER USE, CAUSING THE NURSE TO PUNCTURE."

  Patient problems: Needle Stick/Puncture

  MAUDE report 10093622 ↗
• InjuryFeb 5, 2020Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE NEEDLE ECLIPSE 27X1/2 EXPERIENCED A SAFETY MECHANISM FAILURE DURING USE, AND WAS INVOLVED IN A DIRTY NEEDLE STICK INJURY TO THE NURSE. THE NURSE RECEIVED UNSPECIFIED LAB TESTING AS A RESULT OF THE NEEDLE STICK. IT HAS SINCE BEEN CONFIRMED THAT ALL RESULTS FROM THE TESTING WERE NEGATIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 305758, BATCH NO. UNKNOWN . PER EMAIL: CHC COMPLAINT REFERENCE #: (B)(4). CAT# OF PRODUCT BEING COMPLAINED: 305758 DESCRIPTION OF PRODUCT: NEEDLE ECLIPSE 27GX1/2 IN F/LL SYR 100EA/PK 12PK/CA. LOT OR S/N: UNSURE. COMPLAINT CATEGORY: FAIL TO FUNCTION / DEFECTIVE. REPORTABLE: NO. INCIDENT DATE: (B)(6) 2020. HOSPITAL COMPLAINT REFERENCE #: DETAILS OF COMPLAINT (REPORTED ISSUE): RN NEEDLE STICK. SHE BELIEVES SHE MAY HAVE LOCKED THE SAFETY GUARD BUT NOT QUITE SURE. RN WENT TO PICK IT UP BUT STUCK IN LEFT INDEX FINGER. COMPLAINT NOTICED: PRIOR TO USE. PROBLEM FREQUENCY: 1ST TIME. CUSTOMER EXPOSURE: . PATIENT INJURY: NO. HAS HEALTH CANADA BEEN INFORMED? NO. QTY AFFECTED: 1 EA. SAMPLES AVAILABLE? NO. IS CUSTOMER REQUESTING AN RGA?: NO. ON 01/22/2020: RECEIVED EMAIL: WAS THERE ANY DEFECT OR ISSUE WITH THE ACT

  Patient problems: Exposure to Body Fluids; Needle Stick/Puncture

  MAUDE report 9672789 ↗