BD Eclipse 305761Recalls & reported problems

Summary

The FDA's MAUDE database contains 140 adverse event reports that list this exact device (DI 00382903057610), received between Nov 2, 2017 and Apr 21, 2026 — classified as 16 injuries, 124 malfunctions.

The most frequently reported specific device problem is “Material Protrusion/Extrusion” (33 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 140 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2026Retraction Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24942331 ↗
• MalfunctionJan 27, 2026Retraction Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE 25X1 RB SAFETY MECHANISM FAILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24189510 ↗
• MalfunctionJan 27, 2026Retraction Problem

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE 25X1 RB SAFETY MECHANISM FAILED MATERIAL # 305761, BATCH # 5116272, IT WAS REPORTED BY CUSTOMER THAT A FAILED SAFETY MECHANISM ON AN ECLIPSE NEEDLE. THE SAFETY LOCK MECHANISM ON THE ECLIPSE NEEDLE BROKE OFF AFTER ADMINISTERING IN THE PROCESS OF LOCKING THE NEEDLE. VERBATIM: PER CUSTOMER: A FAILED SAFETY MECHANISM ON AN ECLIPSE NEEDLE. THE SAFETY LOCK MECHANISM ON THE ECLIPSE NEEDLE BROKE OFF AFTER ADMINISTERING IN THE PROCESS OF LOCKING THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24189509 ↗
• MalfunctionJan 27, 2026Break

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE 25X1 RB SAFETY MECHANISM FAILED MATERIAL#: 305761 BATCH#: 5125220 IT WAS REPORTED BY THE CUSTOMER THAT THE SAFETY MECHANISMS BREAKING ON THEM WHEN ENGAGING. RCC RECEIVED A COMPLAINT VIA EMAIL. GOOD MORNING, I AM A PATIENT CARE MANAGER IN A IN WE CURRENTLY USE YOUR BD ECLIPSE NEEDLES AND ARE HAVING ISSUES WITH THE SAFETY MECHANISMS BREAKING ON THEM WHEN ENGAGING. WE HAVE HAD UPWARDS OF 5 REPORTS OF THIS. NORMALLY, OUR CMAS ENGAGE THE SAFETY BY TAPPING IN ON THE EDGE OF A BED OR COUNTER RATHER THAN WITH THEIR FINGER DUE TO THE QUICKNESS OF OUR PROCESS WITH KIDDOS AND HAVING TO SWITCH NEEDLES QUICKLY AND ENGAGE SAFETY WITH ONLY ONE HAND. HAVE YOU HAD THIS ISSUE COME UP AT ALL?

  Patient problems: Needle Stick/Puncture

  MAUDE report 24189504 ↗
• MalfunctionJan 13, 2026Activation Problem

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE 25X1 RB SAFETY MECHANISM FAILED IT WAS REPORTED BY THE CUSTOMER THAT THEY HAVE ENCOUNTERED ISSUES WHERE THE NEEDLES EITHER BROKE WHEN BEING REMOVED FROM THE PACKAGING, SPLIT AT THE END WHERE THEY CONNECT TO THE VACCINE SYRINGE, OR LED TO A SAFETY INCIDENT IN WHICH A STAFF MEMBER WAS POKED BY THE NEEDLE DUE TO A MALFUNCTION. RCC RECEIVED A COMPLAINT VIA EMAIL. WE HAVE RECEIVED A QUALITY COMPLAINT ON PRODUCT SOLD TO OUR CUSTOMER. INJURIES OR ADVERSE EVENT: NO ITEM: 305761 QUANTITIES AFFECTED:2EA SERIAL/LOT NUMBER: (B)(6), PO : (B)(4) ARE ANY SAMPLES AVAILABLE FOR RETURN? YES, REPORTED ISSUE: PER CUSTOMER XXX: OVER THE PAST TWO MONTHS, WE HAVE EXPERIENCED TWO INCIDENTS INVOLVING PATIENTS AND EMPLOYEES RELATED TO THE BD ECLIPSE NEEDLES, 25G X 1. WE HAVE ENCOUNTERED ISSUES WHERE THE NEEDLES EITHER BROKE WHEN BEING REMOVED FROM THE PACKAGING, SPLIT AT THE END WHERE THEY CONNECT TO THE VACCINE SYRINGE, OR LED TO A SAFETY INCIDENT IN WHICH A STAFF MEMBER WAS POKED BY THE NEEDLE DUE TO A MALFUNCTION. TO ENSURE SAFETY, I HAVE REMOVED THESE NEEDLES FROM OUR INVENTORY AND REPLACED THEM WITH THE MAGELLAN SAFETY NEEDLE, 25 G X 1". CUSTOMER DISPOSITION REQUE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24059214 ↗
• MalfunctionJan 13, 2026Break

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE 25X1 RB NEEDLE DAMAGED IT WAS REPORTED BY THE CUSTOMER THAT THEY HAVE ENCOUNTERED ISSUES WHERE THE NEEDLES EITHER BROKE WHEN BEING REMOVED FROM THE PACKAGING, SPLIT AT THE END WHERE THEY CONNECT TO THE VACCINE SYRINGE, OR LED TO A SAFETY INCIDENT IN WHICH A STAFF MEMBER WAS POKED BY THE NEEDLE DUE TO A MALFUNCTION. RCC RECEIVED A COMPLAINT VIA EMAIL. WE HAVE RECEIVED A QUALITY COMPLAINT ON PRODUCT SOLD TO OUR CUSTOMER. INJURIES OR ADVERSE EVENT: NO ITEM: 305761 QUANTITY AFFECTED:2EA SERIAL/LOT NUMBER: (B)(6) PO : (B)(4). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES REPORTED ISSUE: PER CUSTOMER XXX: OVER THE PAST TWO MONTHS, WE HAVE EXPERIENCED TWO INCIDENTS INVOLVING PATIENTS AND EMPLOYEES RELATED TO THE BD ECLIPSE NEEDLES, 25G X 1. WE HAVE ENCOUNTERED ISSUES WHERE THE NEEDLES EITHER BROKE WHEN BEING REMOVED FROM THE PACKAGING, SPLIT AT THE END WHERE THEY CONNECT TO THE VACCINE SYRINGE, OR LED TO A SAFETY INCIDENT IN WHICH A STAFF MEMBER WAS POKED BY THE NEEDLE DUE TO A MALFUNCTION. TO ENSURE SAFETY, I HAVE REMOVED THESE NEEDLES FROM OUR INVENTORY AND REPLACED THEM WITH THE MAGELLAN SAFETY NEEDLE, 25 G X 1". CUSTOMER DISPOSITION REQUEST: CUSTOMER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24059213 ↗
• MalfunctionJan 13, 2026Activation Problem

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE 25X1 RB SAFETY MECHANISM FAILED IT WAS REPORTED BY THE CUSTOMER THAT THEY HAVE ENCOUNTERED ISSUES WHERE THE NEEDLES EITHER BROKE WHEN BEING REMOVED FROM THE PACKAGING, SPLIT AT THE END WHERE THEY CONNECT TO THE VACCINE SYRINGE, OR LED TO A SAFETY INCIDENT IN WHICH A STAFF MEMBER WAS POKED BY THE NEEDLE DUE TO A MALFUNCTION. RCC RECEIVED A COMPLAINT VIA EMAIL. WE HAVE RECEIVED A QUALITY COMPLAINT ON PRODUCT SOLD TO OUR CUSTOMER. INJURIES OR ADVERSE EVENT: NO ITEM: 305761 QUANTITIES AFFECTED:2EA SERIAL/LOT NUMBER: (B)(6), PO : (B)(4) ARE ANY SAMPLES AVAILABLE FOR RETURN? YES, REPORTED ISSUE: PER CUSTOMER XXX: OVER THE PAST TWO MONTHS, WE HAVE EXPERIENCED TWO INCIDENTS INVOLVING PATIENTS AND EMPLOYEES RELATED TO THE BD ECLIPSE NEEDLES, 25G X 1. WE HAVE ENCOUNTERED ISSUES WHERE THE NEEDLES EITHER BROKE WHEN BEING REMOVED FROM THE PACKAGING, SPLIT AT THE END WHERE THEY CONNECT TO THE VACCINE SYRINGE, OR LED TO A SAFETY INCIDENT IN WHICH A STAFF MEMBER WAS POKED BY THE NEEDLE DUE TO A MALFUNCTION. TO ENSURE SAFETY, I HAVE REMOVED THESE NEEDLES FROM OUR INVENTORY AND REPLACED THEM WITH THE MAGELLAN SAFETY NEEDLE, 25 G X 1". CUSTOMER DISPOSITION REQUE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24059210 ↗
• MalfunctionJan 13, 2026Break

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE 25X1 RB NEEDLE DAMAGED IT WAS REPORTED BY THE CUSTOMER THAT THEY HAVE ENCOUNTERED ISSUES WHERE THE NEEDLES EITHER BROKE WHEN BEING REMOVED FROM THE PACKAGING, SPLIT AT THE END WHERE THEY CONNECT TO THE VACCINE SYRINGE, OR LED TO A SAFETY INCIDENT IN WHICH A STAFF MEMBER WAS POKED BY THE NEEDLE DUE TO A MALFUNCTION. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WE HAVE RECEIVED A QUALITY COMPLAINT ON PRODUCT SOLD TO OUR CUSTOMER. INJURIES OR ADVERSE EVENT: NO. ITEM: 305761. QUANTITY AFFECTED:2EA. SERIAL/LOT NUMBER: (B)(6). PO : (B)(6). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE: PER CUSTOMER XXX: OVER THE PAST TWO MONTHS, WE HAVE EXPERIENCED TWO INCIDENTS INVOLVING PATIENTS AND EMPLOYEES RELATED TO THE BD ECLIPSE NEEDLES, 25G X 1. WE HAVE ENCOUNTERED ISSUES WHERE THE NEEDLES EITHER BROKE WHEN BEING REMOVED FROM THE PACKAGING, SPLIT AT THE END WHERE THEY CONNECT TO THE VACCINE SYRINGE, OR LED TO A SAFETY INCIDENT IN WHICH A STAFF MEMBER WAS POKED BY THE NEEDLE DUE TO A MALFUNCTION. TO ENSURE SAFETY, I HAVE REMOVED THESE NEEDLES FROM OUR INVENTORY AND REPLACED THEM WITH THE MAGELLAN SAFETY NEEDLE, 25 G X 1". CUST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24059204 ↗
• MalfunctionDec 24, 2025Mechanical Problem; Fail-Safe Problem; Mechanical Problem; Fail-Safe Problem

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE 25X1 RB SAFETY MECHANISM FAILED. IT WAS REPORTED BY CUSTOMER THAT NEEDLESTICK OCCURRED DUE TO SAFETY DEVICE COMING OFF OF NEEDLE AFTER SAFETY WAS ACTIVATED ON A HARD SURFACE AND NOT USING ONE HANDED METHOD. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. I WAS ASKED TO PASS ALONG A SAFETY ISSUE THAT WAS REPORTED BY XXXXXX CC'D IN THIS EMAIL. PLEASE SEE DETAILS OF THE REPORT BELOW: ¿NEEDLESTICK OCCURRED DUE TO SAFETY DEVICE COMING OFF OF NEEDLE AFTER SAFETY WAS ACTIVATED ON A HARD SURFACE AND NOT USING ONE HANDED METHOD. ENTERED INTO ENTERPRISE ALREADY AND REPORTED ON TIER 3 WITH INVESTIGATION. ADDING FOR XXXX ALERT INVESTIGATION/TRACKING.¿ PRODUCT: BD ECLIPSE IM NEEDLE. 25 G 1 INCH NEEDLE, 3056761 LOT: 4338358 DATE OF INCIDENT: (B)(6) 2025 LOCATION: XXXXXX. ADDITIONAL INFORMATION: NO SAMPLE AVAILABLE PATIENT IMPACT: THE IMPACT WAS TO AN EMPLOYEE, AND THEY UNFORTUNATELY HAD A NEEDLESTICK. WE DID DISCOVER THAT THEY ACTIVATED THE NEEDLE SAFETY ON A HARD SURFACE INSTEAD OF ONE HANDED LIKE THEY ARE SUPPOSED TO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888896 ↗
• MalfunctionDec 19, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE 25X1 RB HAD FOREIGN MATTER. IT WAS REPORTED BY CUSTOMER THAT THEY NOTED A SUBSTANCE INSIDE THE ORANGE NEEDLE HUB. VERBATIM: RCC RECEIVED A COMPLAINT VIA COMMUNITY. PIR ATTACHED CLINICAL STAFF MEMEBER OPENED THE PACKAGE OF THE NEEDLE AND NOTED A SUBSTANCE INSIDE THE ORANGE NEEDLE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23853642 ↗
• MalfunctionDec 11, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE 25X1 RB FOREIGN MATTER. IT WAS REPORTED BY CUSTOMER THAT THEY FOUND A FOREIGN MATERIAL ON THE NEEDLE (AROUND LUER LOCK PART).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23778638 ↗
• MalfunctionNov 25, 2025Shielding Failure; Shielding Failure

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE 25X1 RB SAFETY MECHANISM FAILED IT WAS REPORTED BY CUSTOMER THAT THE SAFETY MECHANISM "POPS OFF" DURING ACTIVATION LEAVING NEEDLE EXPOSED FOR POTENTIAL INJURY VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. NAME: FACILITY NAME: (B)(6). SUMMARY OF ISSUE: SAFETY MECHANISM "POPS OFF" DURING ACTIVATION LEAVING NEEDLE EXPOSED FOR POTENTIAL INJURY DATE OF INCIDENT: (B)(6) 2025 HAS THE PRODUCT/PACKAGING BEEN SAVED? : YES DID HARM OCCUR TO THE PATIENT AS A RESULT OF THIS PRODUCT FAILURE?: NO MANUFACTURER: BD PLEASE PROVIDE ANY OTHER IMPORTANT DETAILS, IF NEEDED. : 25G X 1 INCH TW NEEDLE ARE THERE PHOTOS FOR THIS PRODUCT FAILURE? YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23647351 ↗
• MalfunctionOct 31, 2025Activation Problem; Activation Problem

  DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION, OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. ¿ EMPLOYEE WAS INJURED VIA NEEDLESTICK AND EXPOSED TO A PATIENT¿S BLOOD AND BODILY FLUID. OTHER EMPLOYEES REPORTED THE SAFETY FELL OFF.

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

  MAUDE report 23439909 ↗
• MalfunctionOct 31, 2025Material Perforation; Material Perforation

  (B)(4) SUBMITTED IN ERROR.

  Patient problems: Needle Stick/Puncture

  MAUDE report 23439631 ↗
• MalfunctionOct 27, 2025Break; Break

  AFTER ADMINISTERING IM INJECTION ON PEDIATRIC PATIENT, I ATTEMPTED TO COVER THE NEEDLE WITH THE SAFETY GUARD BY APPLYING LIGHT PRESSURE FROM THE CARSEAT TO THE BACK OF THE DEVICE AS DONE ON NUMEROUS PRIOR INJECTIONS. THE SAFETY BROKE OFF THE NEEDLE AND FELL TO THE GROUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23392136 ↗
• MalfunctionOct 22, 2025Activation Problem; Activation Problem

  MATERIAL#: 305761 BATCH#: 4361971 IT WAS REPORTED BY THE CUSTOMER THAT THE SAFETY FEATURE OF COVERING NEEDLE IS FALLING OFF WHILE TRYING TO UTILIES THE SAFETY. THE TWO EVENTS OCCURRED: 08-10-2025. 09-10-2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23358682 ↗
• MalfunctionOct 22, 2025Activation Problem; Activation Problem

  MATERIAL#: 305761. BATCH#: 4361971. IT WAS REPORTED BY THE CUSTOMER THAT THE SAFETY FEATURE OF COVERING NEEDLE IS FALLING OFF WHILE TRYING TO UTILISE THE SAFETY. THE TWO EVENTS OCCURRED: (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23358681 ↗
• InjuryOct 17, 2025Activation Problem; Activation Problem

  IT WAS REPORTED BY CUSTOMER THAT THE SAFETY ON THE NEEDLE FAILED WHEN ACTIVATED AND THE NEEDLE WENT THRU THE SAFETY COVER PUNCTURING THROUGH MY GLOVE AND CUTTING THEIR FINGER. 20 MIN PRIOR, THIS HAPPENED TO ANOTHER STAFF MEMBER. 2 OTHER STAFF LOST THEIR SAFETY COVERS DURING THE EVENT WITH NO INJURIES

  Patient problems: Needle Stick/Puncture

  MAUDE report 23323553 ↗
• InjuryOct 17, 2025Activation Problem; Activation Problem

  IT WAS REPORTED BY CUSTOMER THAT THE SAFETY ON THE NEEDLE FAILED WHEN ACTIVATED AND THE NEEDLE WENT THRU THE SAFETY COVER PUNCTURING THROUGH MY GLOVE AND CUTTING THEIR FINGER. 20 MIN PRIOR, THIS HAPPENED TO ANOTHER STAFF MEMBER. 2 OTHER STAFF LOST THEIR SAFETY COVERS DURING THE EVENT WITH NO INJURIES

  Patient problems: Needle Stick/Puncture

  MAUDE report 23323540 ↗
• MalfunctionSep 10, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE 25X1 RB - SAFETY MECHANISM FAILURE. IT WAS REPORTED BY CUSTOMER THAT SAFETY DEVICE NOT PREATTACHED TO NEEDLE HUB LEAVING NEEDLE EXPOSED WITH NO WAY TO SAFELY CAP AND DISPOSE OF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23014228 ↗
• MalfunctionAug 15, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE 25X1 RB SAFETY SLEEVE WAS DIFFICULT TO MOVE IT WAS REPORTED BY CUSTOMER THAT THEY SAFETY COMPONENT IS IN THE WAY WHEN DRAWING OR ADMINISTERING MEDICATION, NEEDLES ARE VERY FLIMSY AND BEND EASILY, SEEM TO CAUSE MORE SITE BLEEDING AFTER ADMINISTRATION. VERBATIM: 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT MM-DD-YYYY? ORDERED 02/05/2025 , 02/25/2025, 06/18/2025 OTHERS WERE BACK ORDERED AND THEN OFF FORMULARY 2. COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE ISSUE? SAFETY COMPONENT IS IN THE WAY WHEN DRAWING OR ADMINISTERING MEDICATION, NEEDLES ARE VERY FLIMSY AND BEND EASILY, SEEM TO CAUSE MORE SITE BLEEDING AFTER ADMINISTRATION. 3. CAN YOU PLEASE PROVIDE THE LOT NUMBER ASSOCIATED WITH REPORTED ISSUE? LOT# 4330606 LOT# 4206638 4. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NEEDLES ARE VERY FLIMSY AND BEND EASILY, SEEM TO CAUSE MORE SITE BLEEDING AFTER ADMINISTRATION. 5. ANY SAMPLE AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? XXX

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22818864 ↗
• MalfunctionAug 8, 2025Break; Break

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE 25X1 RB SAFETY SHIELD BROKE OFF (ECLIPSE) IT WAS REPORTED BY CUSTOMER THAT WHEN ATTEMPTING TO LOCK THE NEEDLE AFTER VACCINE ADMINISTRATION THE CAP BREAKS OFF. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. DEFECTIVE PRODUCT: ECLIPSE NEEDLE FOR LUER-LOK SYRINGES, ORANGE HUB, 25G X 1¿ MANF # 305761. CONCERN: FROM (B)(6): WHEN ATTEMPTING TO LOCK THE NEEDLE AFTER VACCINE ADMINISTRATION THE CAP BREAKS OFF. THIS HAPPENED THIS MORNING WITH MY BACK OFFICE VISIT I HAD. I ADMINISTERED THE FIRST VACCINE AND STILL HAD A SECOND ONE TO ADMINISTER. I MADE SURE PARENT HELPED ME HOLD BABIES' ARMS SO THAT THE BABY WOULD NOT TOUCH THE NEEDLE THAT WAS ON MY TRAY. I FEEL THAT THESE NEEDLES ARE VERY UNSAFE, AND I DON'T FEEL SAFE USING THEM AS WELL. SOME OF THE OTHER CAREGIVERS HAVE EXPERIENCED THIS ISSUE AS WELL. THIS IS A RECENT CONVERSION DUE TO A CHANGE IN THE (B)(6). I BELIEVE THAT THERE WAS NOT ANY EDUCATION GIVEN AND THIS MAY BE A NEED. CUSTOMER RESPONSE ON 25-JUL-2025. BD TEAM, FOR YOUR INFORMATION: THE CONCERN THAT YOU RECEIVED FROM ME WAS PROVIDED BY (B)(6). MY PART OF THE PROCESS IS TO BE SURE THAT THE CONCERNS OF THE CAREGIVER ARE PASSE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22750132 ↗
• MalfunctionAug 8, 2025Break; Break

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE 25X1 RB SAFETY SHIELD BROKE OFF (ECLIPSE) IT WAS REPORTED BY CUSTOMER THAT WHEN ATTEMPTING TO LOCK THE NEEDLE AFTER VACCINE ADMINISTRATION THE CAP BREAKS OFF. RCC RECEIVED A COMPLAINT VIA EMAIL. DEFECTIVE PRODUCT: ECLIPSE NEEDLE FOR LUER-LOK SYRINGES, ORANGE HUB, 25G X 1¿ MANF#: 305761 CONCERN: FROM XXX: WHEN ATTEMPTING TO LOCK THE NEEDLE AFTER VACCINE ADMINISTRATION THE CAP BREAKS OFF. THIS HAPPENED THIS MORNING WITH MY BACK-OFFICE VISIT I HAD. I ADMINISTERED THE FIRST VACCINE AND STILL HAD A SECOND ONE TO ADMINISTER. I MADE SURE PARENT HELPED ME HOLD BABIES' ARMS SO THAT THE BABY WOULD NOT TOUCH THE NEEDLE THAT WAS ON MY TRAY. I FEEL THAT THESE NEEDLES ARE VERY UNSAFE, AND I DON'T FEEL SAFE USING THEM AS WELL. SOME OF THE OTHER CAREGIVERS HAVE EXPERIENCED THIS ISSUE AS WELL. THIS IS A RECENT CONVERSION DUE TO A CHANGE IN THE XXX. I BELIEVE THAT THERE WAS NOT ANY EDUCATION GIVEN AND THIS MAY BE A NEED. CUSTOMER RESPONSE ON (B)(6) 2025. BD TEAM, FOR YOUR INFORMATION: THE CONCERN THAT YOU RECEIVED FROM ME WAS PROVIDED BY XXX. MY PART OF THE PROCESS IS TO BE SURE THAT THE CONCERNS OF THE CAREGIVER ARE PASSED TO THE CORRECT PLACE SO THAT WE CAN W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22749967 ↗
• MalfunctionJun 16, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE 25X1 RB SAFETY MECHANISM FAILED IT WAS REPORTED BY CUSTOMER THAT THE NEEDLE SAFETY IS POPPING OFF INSTEAD OF FLIPPING OVER THE NEEDLE. RCC RECEIVED A COMPLAINT VIA EMAIL. I RECEIVED NOTICE THAT WE ARE HAVING ISSUES WITH THE BELOW ITEM. THE NEEDLE SAFETY IS POPPING OFF INSTEAD OF FLIPPING OVER THE NEEDLE ¿ AS DESIGNED. THIS HAS OCCURRED SPECIFICALLY WITH THE BELOW LOT NUMBER. THE DEPARTMENT IS PULLING THE INVOLVED LOT ¿ AS WE ARE CONCERNED OF NEEDLE STICKS. BD ECLIPSE NEEDLE 25GX1¿ ¿ LOT # 4237565 EXP: 8/31/2029 MFG DATE: 9/1/2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22215819 ↗
• MalfunctionJun 10, 2025Break; Break

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE 25X1 RB NEEDLE PULLED OUT OF HUB IT WAS REPORTED BY CUSTOMER THAT WHEN PLACING THE NEEDLE TIP ON THE VACCINE NEEDLE CAME APART IN THE CUSTOMER'S HAND. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. THE CUSTOMER WAS PREPPING A VACCINE AND OPENED THE NEEDLE TIP BY PRODUCT INSTRUCTIONS. WHEN PLACING THE NEEDLE TIP ON THE VACCINE NEEDLE CAME APART IN THE CUSTOMER'S HAND. COVER SAFETY LATCH CAME AWAY FROM THE NEEDLE. NEEDLE CAP WAS LOSSY LEFT ON. THE CUSTOMER WAS ABLE TO REMOVE THE SAFETY NEEDLE SAFELY AND DISCARD. THE CUSTOMER STATES THEY HAVEN'T HAD A PROBLEM WITH THIS BATCH BEFORE OR SINCE THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22177096 ↗