BD Eclipse 305763Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00382903057634), received between Jan 8, 2018 and Jun 21, 2024 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Material Protrusion/Extrusion” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 21, 2024Complete Blockage; Complete Blockage

  MATERIAL # 305763, LOT # 1118936. IT WAS REPORTED BY CUSTOMER THAT THE PRESSURE THAT NEEDS TO BE USED IS TOO EXCESSIVE AND WILL CAUSE INJURY TO THE DR. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. PLEASE FOLLOW UP WITH XXX AT XXX (EXT: (B)(6) FOR THE PRODUCT CONCERN OUTLINED BELOW WITHIN 3 BUSINESS DAYS; AND ADVISE OF ANY SPECIAL SHIPPING INSTRUCTIONS FOR PICK UP, COURIER OR DISCARDING OF PRODUCT. PLEASE INVESTIGATE AND FOLLOW UP WITH A WRITTEN REPORT FROM YOUR QUALITY ASSURANCE AS TO YOUR FINDINGS AND RESOLUTIONS. PRODUCT CONCERN TICKET NUMBER: (B)(4). DATE OF INCIDENT: (B)(6) 2024. HOSPITAL: (B)(6). PRODUCT: NEEDLE SAFE 22G X 1.5 305763. VMID: (B)(4). LOT NUMBER: 1118936. PRODUCT EXPIRY DATE: 30-APR-2026. NUMBER OF DEFECTIVE PRODUCT(S): 1. IS SAMPLE AVAILABLE: YES. CONCERN DESCRIPTION: 23G NEEDLE IS NOT SUITABLE FOR BREAST ASPIRATIONS. THE PRESSURE THAT NEEDS TO BE USED IS TOO EXCESSIVE AND WILL CAUSE INJURY TO THE DR. 21G IS TOO SMALL FOR THE ASPIRATE. THANK YOU IN ADVANCE FOR YOUR FOLLOW-UP ON THIS PRODUCT CONCERN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19584358 ↗
• MalfunctionDec 27, 2021Break; Break

  IT WAS REPORTED THAT 1 BD ECLIPSE¿ NEEDLE BROKE OFF . THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CUSTOMER STATED THAT THE NEEDLE BROKE DURING USE. DATE REPORTED : (B)(6) 2021; SAMPLE RECEIVED : NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13090652 ↗
• InjuryJun 15, 2021Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT NEEDLE ECLIPSE 22X1-1/2 RB EXPERIENCED A CASE OF SAFETY MECHANISM FAILURE, DIFFICULTY ENGAGING THE SAFETY MECHANISM, AND A SAFETY MECHANISM THAT WOULD NOT ENGAGE. THE PRODUCT DEFECT RESULTED IN A DIRTY NEEDLE STICK INJURY. IT HAS NOT BEEN SPECIFIED WHETHER MEDICAL INTERVENTION WAS APPLIED AS A RESULT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305763, BATCH NO: UNKNOWN. SAFETY COVERS ON ITEM DO NOT CLOSE EASILY/COMPLETELY AND OFTEN STICK OR NEED TO BE FORCED CLOSED. THIS HAS RESULTED IN A NEEDLE STICK INJURY TO ONE STAFF MEMBER AND MULTIPLE CLOSE CALLS WITH OTHER MEMBERS OF OUR UNIT STAFF. THE NEEDLE WAS DIRTY/POST USE AT TIME OF THE NEEDLE STICK. TYPE OF INCIDENT/PROBLEM: MALFUNCTION - DURING OR AFTER USE. LEVEL OF HARM: MINIMAL HARM. WHO WAS AFFECTED? HEALTH CARE PROFESSIONAL. UNEXPECTED OR PROLONGED CARE? UNKNOWN. FREQUENCY OF PROBLEM: FIRST TIME.

  Patient problems: Insufficient Information; Needle Stick/Puncture

  MAUDE report 12006074 ↗
• MalfunctionApr 21, 2021Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE BD ECLIPSE¿ HYPODERMIC NEEDLE SAFETY LOCK FELL OFF WHEN ENGAGING IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SAFETY LOCK OF NEEDLE FALLS OFF WHEN UNCAPPING AND WHEN ENGAGING SAFETY LOCK."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11704324 ↗
• InjuryOct 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 2 PATIENTS DEVELOPED CELLULITIS AFTER THE BD ECLIPSE HYPODERMIC NEEDLES WERE USED ON THEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AFTER INJECTING INTO THE PATIENT WITH DRUG, CELLULITIS OCCURRED IN TWO DIFFERENT PEOPLE".

  Patient problems: Cellulitis; Unspecified Infection

  MAUDE report 10723560 ↗
• MalfunctionOct 22, 2020Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT NEEDLE ECLIPSE 22X1-1/2 RB PACKAGE WAS DAMAGED. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BEFORE USE, THE USER FOUND THAT THE SEAL WERE OPENED.

  Patient problems: No Patient Involvement

  MAUDE report 10723097 ↗
• MalfunctionMar 24, 2020Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT NEEDLE ECLIPSE 22X1-1/2 RB CAME WITHOUT A SHIELD. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305763, BATCH NO.: 9056795. IT WAS REPORTED THAT THE NEEDLE WAS FOUND WITHOUT A SHIELD AND ALREADY OPEN. PER EMAIL: ONE OF THE TECHS OPENED AN ANGIO PACK, AND FOUND OUT ONE OF THE SAFETY NEEDLES WITHOUT A CAP AND OPEN. HE DID NOT STICK HIMSELF, BUT THOUGHT WE SHOULD REPORT FOR QUALITY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9873837 ↗
• MalfunctionOct 24, 2019Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE SAFETY MECHANISM DID NOT WORK EASILY WITH A BD NEEDLE ECLIPSE 22X1-1/2. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (3 OF 4 COMPLAINTS). IT WAS REPORTED THAT SAFETY MECHANISMS DO NOT SNAP CLOSED EASILY. WE NEED TO BE ABLE TO SINGLE HAND CLOSE THE NEEDLE SO WE DON¿T HAVE TO TAKE THE OTHER HAND OFF THE PATIENT (ESPECIALLY IF IT¿S A KICKING/SCREAMING CHILD), HOWEVER, USING THESE NEEDLES WE HAVE TO USE BOTH HANDS TO ENSURE ITS LOCKED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9234216 ↗
• MalfunctionSep 23, 2019Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT HAS BEEN REPORTED THAT ONE NEEDLE ECLIPSE 22X1-1/2 RB HAS BEEN FOUND WITH THE SAFETY MECHANISM DETACHING. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT A NEEDLE GUARD THAT FELL OFF AN ECLIPSE NEEDLE. I RECEIVED OF A REPORT OF A NEEDLE GUARD THAT FELL OFF AN ECLIPSE NEEDLE. THEY HAVE RETAINED THE DEVICE. NEEDLE GUARD FELL OFF OF NEEDLE WHILE ADMINISTERING MEDICATION. BD ECLIPSE NEEDLE 22 G X 1.5 MM X 40 MM NEEDLE; MANUFACTURED BY BD; LOT #: 8333651; EXP 11/30/2023. NAME OF DEVICE/SUPPLY/IMPLANT INVOLVED: BD ECLIPSE NEEDLE NAME OF MANUFACTURER : BD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9106613 ↗
• MalfunctionMar 1, 2019Fail-Safe Problem

  IT WAS REPORTED THAT TWO NEEDLE ECLIPSE 22X1-1/2 RB EXPERIENCED SAFETY FAILURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8384135 ↗
• InjuryFeb 26, 2019Fail-Safe Did Not Operate

  IT WAS REPORTED THAT A NURSE SUSTAINED A DIRTY NEEDLE STICK INJURY FROM THE BD ECLIPSE¿ HYPODERMIC NEEDLE DURING AN "EMERGENCY IM INJECTION TO AN AGITATED RESIDENT". A "PORTION OF THE PLASTIC COVER" FAILED TO SHIELD PART OF THE NEEDLE ONCE ACTIVATED, RESULTING IN A PRICK TO THE NURSE'S HAND. HOWEVER, NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 8370354 ↗
• MalfunctionJan 8, 2018Detachment Of Device Component

  IT WAS REPORTED THAT THE SAFETY SHIELD ON A BD ECLIPSE¿ HYPODERMIC NEEDLE FELL OFF BEFORE USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7173024 ↗