BD Eclipse 305759Recalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 00382903057597), received between Mar 1, 2018 and Feb 11, 2026 — classified as 1 injury, 58 malfunctions.

The most frequently reported specific device problem is “Material Protrusion/Extrusion” (14 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 59 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2026Contamination /Decontamination Problem

  IT WAS REPORTED BY CUSTOMER THAT THE BD ECLIPSE 5/8" INCH NEEDLE AT BASE OF NEEDLE HAS WHAT APPEARS TO BE PAINT ON IT. RCC RECEIVED A COMPLAINT VIA EMAIL. INCIDENT OR PROBLEM INFORMATION DATE OF INCIDENT (YYYY-MM-DD): (B)(6) 2026 TYPE OF INCIDENT/PROBLEM: A1. DEFECT (OBSERVED PRIOR TO USE) LEVEL OF HARM: NO EFFECT - DID NOT REACH PATIENT/PERSON -- DETECTED BEFORE USE OR DOES NOT TOUCH PATIENT DURING USE INCIDENT DETAILS: BD ECLIPSE 5/8" INCH NEEDLE AT BASE OF NEEDLE HAS WHAT APPEARS TO BE PAINT ON IT UNEXPECTED OR PROLONGED CARE? NO FREQUENCY OF PROBLEM: UNKNOWN OTHER DEVICE/INCIDENT FACTORS: INVASIVE PROCEDURE? NO THERE WAS NO SERIOUS HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24314948 ↗
• MalfunctionDec 2, 2025Retraction Problem; Retraction Problem

  MATERIAL # 305759, LOT #5149514. IT WAS REPORTED BY CUSTOMER THAT THIS ITEM IS A SUB AND HAVING PROBLEMS WITH IT, THE PINK COVER IS SOMETIMES FALLING OFF WHICH IS THE SEMD COVER, TO ACTIVATE THE SEMD COVER YOU HAVE TO GET YOUR FINGERS VERY CLOSE TO THE NEEDLE, THE NEEDLE IS SHORT SO DIFFICULT TO AVOID, AND RN HAD A NEEDLESTICK INJURY.

  Patient problems: Needle Stick/Puncture

  MAUDE report 23694884 ↗
• MalfunctionNov 25, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE IT WAS REPORTED BY CUSTOMER THAT THE NEEDLE AND LUER LOCK POPPED OFF THE SYRINGE VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WHILE PUSHING THE PLUNGER TO ADMINISTER A VACCINE, THE NEEDLE AND LUER LOCK POPPED OFF THE SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23647878 ↗
• MalfunctionOct 22, 2025Leak/Splash; Leak/Splash

  VERBATIM: LEAKING AT THE LUER CONNECTION OF THE NEEDLE. THEY SAID THAT IT OCCURS WHEN CONNECTED TO A SYRINGE AND WHEN CONNECTED TO A PHASEAL CONNECTOR SO THEY'RE CONFIDENT IT'S THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23357204 ↗
• MalfunctionOct 22, 2025Leak/Splash; Leak/Splash

  VERBATIM: LEAKING AT THE LUER CONNECTION OF THE NEEDLE. THEY SAID THAT IT OCCURS WHEN CONNECTED TO A SYRINGE AND WHEN CONNECTED TO A PHASEAL CONNECTOR SO THEY'RE CONFIDENT IT'S THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23357202 ↗
• MalfunctionAug 13, 2025Activation Failure; Activation Failure

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE 25X5/8 - SAFETY MECHANISM FAILURE. MATERIAL#: 305759. BATCH#: 4250308. IT WAS REPORTED BY CUSTOMER THAT SAFETY LOCK ON NEEDLE DID NOT SECURE LEAVING SHARP EXPOSED AND WHEN DISPOSING NEEDLE IN SHARPS CONTAINER POKED EMPLOYEE THROUGH GLOVES INTO THUMB PRODUCING BLOOD.

  Patient problems: Needle Stick/Puncture

  MAUDE report 22794330 ↗
• MalfunctionAug 12, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE 25X5/8 SAFETY SLEEVE 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: RCC RECEIVED A COMPLAINT VIA EMAIL. WE ARE HAVING ISSUES WITH THE BD ECLIPSE NEEDLES IN 3 OTHER CLINIC LOCATIONS IN XXX. I AM INCLUDING THEM ON THIS EMAIL, AND I AM HOPEFUL THAT YOU CAN REACH OUT TO THEM AND GET THE INFORMATION THAT YOU NEED. XXX, IF YOU COULD REACH OUT TO THEM WITH THE EDUCATION INFO AND ANY OTHER HELPS, I WOULD APPRECIATE IT. 25G NEEDLE B-D305759 XXX IS AT THE XXX XXX; 25G NEEDLE, NEW I HAVEN¿T RECEIVED WORD ON WHICH SPECIFIC MODEL YET. XXX IS AT XXX XXX HUB NEEDLE COMBO. IS AT CUSTOMER RESPONSE ON 30-JUL-2025. 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 BLEE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22784366 ↗
• MalfunctionJul 28, 2025Material Protrusion/Extrusion; Sharp Edges

  SAFETY LOCK ON NEEDLE DID NOT SECURE LEAVING SHARP EXPOSED AND WHEN DISPOSING NEEDLE IN SHARPS CONTAINER POKED EMPLOYEE THROUGH GLOVES INTO THUMB PRODUCING BLOOD.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22628608 ↗
• MalfunctionJul 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE SAFETY SHIELD BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SAFETY BROKE OFF WHEN THEY WENT TO ACTIVATE ON (B)(6) 2025. I GAVE AN INJECTION IN CHILD'S R THIGH AND BEFORE I COULD ENGAGE THE SAFETY FEATURE, THE PIECE OFF THE NEEDLE AND LANDED ON THE FLOOR. IT WAS A BD ECLIPSE 25G X 5/8" TW. (B)(6) 2025. WHAT IS THE DATE OF EVENT? I THINK IT WAS 6/10/25 BUT I AM NOT POSITIVE ON THAT. THE DAY I PUT THE COMPLAINT IN WAS THE DATE IT HAPPENED (COMPLAINT ENTERED 6/19). DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO PATIENT HARM OR NEGATIVE OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22410753 ↗
• MalfunctionJun 30, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE 25X5/8 SAFETY SHIELD BROKE OFF IT WAS REPORTED BY CUSTOMER THAT SAFTEY SLIPPED OFF ORANGE CONNECTOR WHEN STAFF ATTEMPTED TO APPLY IT. RCC RECEIVED A COMPLAINT VIA EMAIL. SAFTEY SLIPPED OFF ORANGE CONNECTOR WHEN STAFF ATTEMPTED TO APPLY IT. I SUBMITTED THE UO AND THE NUMBER IS 25-6433 XXXXX HAD AN ISSUE WITH A NEEDLE THAT WHEN SHE WENT TO APPLY THE SAFETY, IT BROKE OFF. SHE DOES HAVE THE SAFETY PIECE IF WE NEED TO SEND IT IN, THE NEEDLE WAS DISCARDED. PLEASE LET ME KNOW IF YOU NEED ANY FURTHER INFORMATION! THANKS! I AM ASSUMING THIS IS ON ONE OF THE NEW XX ECLIPSE NEEDLES CAN YOU FILL OUT A DEFECTIVE PRODUCT FORM BY CHANCE? SEE ATTACHED. PLEASE SEND ME A COPY OF IT ONCE IT HAS BEEN COMPLETED FOR MY TRACKING PURPOSES. I AM INCLUDING XXXXXXXXX FROM XX TO SEE IF SHE CAN ASSIST WITH REPORTING THIS TO THE COMPANY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22358929 ↗
• MalfunctionMay 19, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD NEEDLE ECLIPSE 25X5/8 HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL: 305759 BATCH#: UNKNOWN (PROVIDED LOT#2006005) VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. REFERENCE NUMBER (ID): (B)(4) DATE OF INCIDENT: (B)(6) 2025 LEVEL OF HARM: NO APPARENT HARM - REACHED THE PATIENT/PERSON -- INCONVENIENT INCIDENT DETAILS: WRITER WAS ADMINISTERING PRN DILAUDID 6MG (0.6ML), WHEN PLUNGER WAS PUSHED, THE ENTIRETY OF THE MEDICATION SPILLED OUT THE SIDE OF THE SYRINGE AT THE LEUR-LOCK SITE DESPITE NO CROSS THREADING OF THE NEEDLE TO THE 1CC SYRINGE. WRITER INFORMED CHARGE NURSE OF THIS AND SHOWED THE MEDICATION PRESENT ON THE PATIENT'S SWEATPANTS TO AID AS EVIDENCE THAT NO AMOUNT OF THE MEDICATION WAS ADMINISTERED. WRITER PULLED ANOTHER VIAL AND ADMINISTERED THE MEDICATION WITH A DIFFERENT SYRINGE (TUBERCULIN SYRINGE WITH NEEDLE ALREADY ATTACHED). OTHER COWORKERS HAVE NOTICED ISSUES WITH THIS SAME PRODUCT, IT IS SOLEY MANUFACTURER ERROR AS WRITER ENSURED NO CROSS THREADING. PRODUCT DOES NOT FIT ON 1CC SYRINGE. PRODUCT: BD ECLIPSE NEEDLE 25G X5/8 (0.5MM X16 MM) INJECTION NEEDLE LOT #: 20066005 DEVICE NAME/DESCR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22047775 ↗
• MalfunctionMar 28, 2025Material Separation; Material Protrusion/Extrusion; Material Separation; Material Protrusion/Extrusion

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE 25X5/8 SYRINGE NEEDLE CONNECTIVITY ISSUE AND SAFETY MECHANISM FAILURE. IT WAS REPORTED BY CUSTOMER THAT THE NEEDLE CAME OFF OF SYRINGE AND FELL ON THE FLOOR. WHEN PICKED UP, THE SAFETY WAS NOT FULLY CLOSED. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. AFTER GIVING A SHOT, WENT TO CLOSE THE SAFETY ON THE NEEDLE AND THE NEEDLE CAME OFF OF SYRINGE AND FELL ON THE FLOOR. WHEN PICKED UP, THE SAFETY WAS NOT FULLY CLOSED. THE NEEDLE SAFETY WAS CLOSED CAREFULLY WHILE STILL ON THE FLOOR. LOT - 4250308.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21720578 ↗
• MalfunctionDec 13, 2024Break; Break

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE 25X5/8 SYRINGE NEEDLE CONNECTIVITY ISSUE. IT WAS REPORTED BY CUSTOMER THAT AFTER INJECTION TO PATIENT, NURSE REMOVED NEEDLE FROM THE PATIENT. NURSE ATTEMPTED TO ENGAGE THE SAFETY COVER, AND THE NEEDLE DISCONNECTED FROM THE SYRINGE CAUSING IT TO FLY AND LAND ON THE TOP OF THE OTHER HAND RESULTING IN A NEEDLE STICK TO NURSE. RCC RECEIVED A COMPLAINT VIA EMAIL. AFTER INJECTION TO PATIENT, NURSE REMOVED NEEDLE FROM THE PATIENT. NURSE ATTEMPTED TO ENGAGE THE SAFETY COVER, AND THE NEEDLE DISCONNECTED FROM THE SYRINGE CAUSING IT TO FLY AND LAND ON THE TOP OF THE OTHER HAND RESULTING IN A NEEDLE STICK TO NURSE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 20928486 ↗
• MalfunctionOct 22, 2024Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE 25X5/8 SAFETY MECHANISM FAILURE. IT WAS REPORTED BY THE CUSTOMER THAT THE SAFETY COVER DID NOT CLIP OVER NEEDLE AND COVER NEEDLE AFTER INJECTING. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. (B)(4). PRODUCT PROBLEM REPORT: PRODUCT INFORMATION: PRODUCT CODE: 305781. PRODUCT DESCRIPTION: SYRINGE & NEEDLE 3CC 25G X 5/8IN & SAFETY ECLIPSE BX/50. LOT/SERIAL #: (B)(6). EXPIRY DATE: 2028-12-31. PROBLEM INFORMATION: CITE CUSTOMER COMPLAINT# (B)(4). INCIDENT DATE: 22-09-2024. THE SAFETY COVER DID NOT CLIP OVER NEEDLE AND COVER NEEDLE AFTER INJECTING.

  Patient problems: Needle Stick/Puncture

  MAUDE report 20509627 ↗
• MalfunctionOct 4, 2024Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE 25X5/8 SAFETY MECHANISM FAILED. IT WAS REPORTED BY CUSTOMER THAT THEY ARE HAVING SOME SAFETY ISSUES WITH OUR BD NEEDLES. ON MULTIPLE OCCASIONS THE PINK SAFETY SHIELD HAS POPPED OFF AND ALSO WHEN WE ARE SCREWING IT ON TO THE VIALS SOMETIMES IT BREAKS OFF. THIS HAPPENED TO ME PERSONALLY BEFORE AND YESTERDAY IT HAPPENED TO ONE OF OUR OTHER LVNS WHO ACTUALLY HAD A NEEDLE STICK INCIDENT. THIS IS REALLY DANGEROUS WORKING WITH OUR PEDIATRIC PATIENTS BECAUSE SOMETIMES THEY HAVE FAST HANDS TOO AND I WOULD HATE FOR ONE OF THEM TO BE POKED VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. ITEM: 305759.. QUANTITY AFFECTED: 5 BX. LOT NUMBER: 4023388. PO : (B)(4). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE: WE ARE HAVING SOME SAFETY ISSUES WITH OUR BD NEEDLES. ON MULTIPLE OCCASIONS THE PINK SAFETY SHIELD HAS POPPED OFF AND ALSO WHEN WE ARE SCREWING IT ON TO THE VIALS SOMETIMES IT BREAKS OFF. THIS HAPPENED TO ME PERSONALLY BEFORE AND YESTERDAY IT HAPPENED TO ONE OF OUR OTHER LVNS WHO ACTUALLY HAD A NEEDLE STICK INCIDENT. THIS IS REALLY DANGEROUS WORKING WITH OUR PEDIATRIC PATIENTS BECAUSE SOMETIMES THEY HAVE FAST HANDS TOO AND I

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

  MAUDE report 20371077 ↗
• MalfunctionOct 4, 2024Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE 25X5/8 SAFETY SHIELD BROKE OFF. IT WAS REPORTED BY CUSTOMER THAT THEY ARE WE ARE HAVING SOME SAFETY ISSUES WITH OUR BD NEEDLES. ON MULTIPLE OCCASIONS THE PINK SAFETY SHIELD HAS POPPED OFF AND ALSO WHEN WE ARE SCREWING IT ON TO THE VIALS SOMETIMES IT BREAKS OFF. THIS HAPPENED TO ME PERSONALLY BEFORE AND YESTERDAY IT HAPPENED TO ONE OF OUR OTHER LVNS WHO ACTUALLY HAD A NEEDLE STICK INCIDENT. THIS IS REALLY DANGEROUS WORKING WITH OUR PEDIATRIC PATIENTS BECAUSE SOMETIMES THEY HAVE FAST HANDS TOO AND I WOULD HATE FOR ONE OF THEM TO BE POKED. RCC RECEIVED A COMPLAINT VIA EMAIL. ITEM: 305759 QUANTITY AFFECTED: 5 BX SERIAL/LOT NUMBER: (B)(6) PO: (B)(4). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES REPORTED ISSUE: WE ARE HAVING SOME SAFETY ISSUES WITH OUR BD NEEDLES. ON MULTIPLE OCCASIONS THE PINK SAFETY SHIELD HAS POPPED OFF AND ALSO WHEN WE ARE SCREWING IT ON TO THE VIALS SOMETIMES IT BREAKS OFF. THIS HAPPENED TO ME PERSONALLY BEFORE AND YESTERDAY IT HAPPENED TO ONE OF OUR OTHER LVNS WHO ACTUALLY HAD A NEEDLE STICK INCIDENT. THIS IS REALLY DANGEROUS WORKING WITH OUR PEDIATRIC PATIENTS BECAUSE SOMETIMES THEY HAVE FAST HANDS TOO AND I WOULD HATE FOR ONE O

  Patient problems: Needle Stick/Puncture

  MAUDE report 20370900 ↗
• MalfunctionOct 3, 2024Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE 25X5/8 SAFETY SHIELD BROKE OFF . IT WAS REPORTED BY CUSTOMER THAT THEY ARE WE ARE HAVING SOME SAFETY ISSUES WITH OUR BD NEEDLES. ON MULTIPLE OCCASIONS THE PINK SAFETY SHIELD HAS POPPED OFF AND ALSO WHEN WE ARE SCREWING IT ON TO THE VIALS SOMETIMES IT BREAKS OFF. THIS HAPPENED TO ME PERSONALLY BEFORE AND YESTERDAY IT HAPPENED TO ONE OF OUR OTHER LVNS WHO ACTUALLY HAD A NEEDLE STICK INCIDENT. THIS IS REALLY DANGEROUS WORKING WITH OUR PEDIATRIC PATIENTS BECAUSE SOMETIMES THEY HAVE FAST HANDS TOO AND I WOULD HATE FOR ONE OF THEM TO BE POKED. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. ITEM: 305759. QUANTITY AFFECTED: (B)(4). SERIAL/LOT NUMBER:(B)(6) . PO : (B)(4). ITEM: 305759. QUANTITY AFFECTED: (B)(4) . SERIAL/LOT NUMBER: (B)(6) . PO :(B)(4),REPORTED ISSUE: WE ARE HAVING SOME SAFETY ISSUES WITH OUR BD NEEDLES. ON MULTIPLE OCCASIONS THE PINK SAFETY SHIELD HAS POPPED OFF AND ALSO WHEN WE ARE SCREWING IT ON TO THE VIALS SOMETIMES IT BREAKS OFF. THIS HAPPENED TO ME PERSONALLY BEFORE AND YESTERDAY IT HAPPENED TO ONE OF OUR OTHER LVNS WHO ACTUALLY HAD A NEEDLE STICK INCIDENT. THIS IS REALLY DANGEROUS WORKING WITH OUR PEDIATRIC PAT

  Patient problems: Needle Stick/Puncture

  MAUDE report 20364306 ↗
• MalfunctionSep 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  MATERIAL#: 305759, BATCH#: 4023388. IT WAS REPORTED BY THE CUSTOMER THAT WHEN USING BD SAFETY ECLIPSE, THE PINK SHIELD DETACHED FROM THE SYRINGE WHEN NURSE WENT TO ACTIVATE THE SAFETY. THE LEFT THE NEEDLE UNSHIELDED AND AT RISK FOR A NEEDLESTICK INJURY. VERBATIM: WHEN USING BD SAFETY ECLIPSE, THE PINK SHIELD DETACHED FROM THE SYRINGE WHEN NURSE WENT TO ACTIVATE THE SAFETY. THE LEFT THE NEEDLE UNSHIELDED AND AT RISK FOR A NEEDLESTICK INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20276006 ↗
• MalfunctionJun 4, 2024Difficult or Delayed Activation; Difficult to Advance; Difficult or Delayed Activation; Difficult to Advance

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE 25X5/8 HAD SHIELD DAMAGED. IT WAS REPORTED BY CUSTOMER THAT THE QUALITY OF THE PLASTIC OF THE IS VERY RIGID, AND BREAKS WHEN TRYING TO MOVE THE SAFETY COVER (EITHER PULLING BACK OR PUSHING DOWN). VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. CHC COMPLAINT REFERENCE #: XXX CUSTOMER (HOSPITAL) NAME: XXX CUSTOMER ADDRESS: XXX CONTACT NAME: XXX PHONE: XXX E-MAIL: XXX CORRESPONDENCE LANGUAGE: ENGLISH CAT# OF PRODUCT BEING COMPLAINED: BD305762 DESCRIPTION OF PRODUCT: NEEDLE ECLIPSE 23GX1IN LL SYR SP=PK 100EA/PK 12PK/CA LOT OR S/N: (B)(6) COMPLAINT CATEGORY: FAIL TO FUNCTION / DEFECTIVE RGA NUMBER: REPORTABLE: NO INCIDENT DATE: (B)(6) 2024 HOSPITAL COMPLAINT REFERENCE #: DETAILS OF COMPLAINT (REPORTED ISSUE): WE HAVE AN ISSUE WITH THE BD ECLIPSE NEEDLES THAT WERE BOUGHT BETWEEN JANUARY 12TH AND FEBRUARY 20TH, SPECIFICALLY PRODUCTS BD305759 AND BD305762. WE HAVE NOTICED THAT THE QUALITY OF THE PLASTIC OF THE IS VERY RIGID, AND BREAKS WHEN TRYING TO MOVE THE SAFETY COVER (EITHER PULLING BACK OR PUSHING DOWN). THIS HAS RESULTED IN INJURIES TO THE TECHNICIANS ADMINISTERING THE MEDICATION, AND ALSO TO THE PATIENT RECEIVING THE MEDICATIO

  Patient problems: Needle Stick/Puncture

  MAUDE report 19461904 ↗
• MalfunctionFeb 29, 2024Missing Information; Missing Information

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE 25X1 RB LABEL CONTENT WAS MISSING THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THE OUR STAFF NOTICED A MISS LABEL ON (B)(4) BOXES OF NEEDLES. PLEASE SEE THE PIC PROVIDED. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. CAT# OF PRODUCT BEING COMPLAINED: BD305761 DESCRIPTION OF PRODUCT: NEEDLE ECLIPSE 25GX1IN USE LL SP=PK 100EA/PK 12PK/CA. LOT OR S/N: (B)(6). COMPLAINT CATEGORY: LABELLING ISSUE REPORTABLE: NO. INCIDENT DATE: (B)(6) 2024. HOSPITAL COMPLAINT REFERENCE #: DETAILS OF COMPLAINT (REPORTED ISSUE): OUR STAFF NOTICED A MISS LABEL ON(B)(4) BOXES OF NEEDLES. PLEASE SEE THE PIC PROVIDED. I BELIEVE ONLY PART OF THE CASE WAS IMPACTED. COMPLAINT NOTICED: PRIOR TO USE. PROBLEM FREQUENCY: 1ST TIME. CUSTOMER EXPOSURE: PATIENT INJURY: NO. HAS HEALTH CANADA BEEN INFORMED? NO. QTY AFFECTED: (B)(4). SAMPLES AVAILABLE? NO. IS CUSTOMER REQUESTING AN RGA?: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18809295 ↗
• MalfunctionFeb 28, 2024Leak/Splash; Leak/Splash

  MATERIAL#: 305759 , LOT#: 2011005 ,2011009, 2007005. IT WAS REPORTED BY THE CUSTOMER THAT THEY NOTICED THE MEDICATION WAS LEAKING OUT. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. QUALITY ISSUE PRODUCT PERFORMANCE (LEAKING). WHEN THE NURSES START INJECTING MEDICATIONS, THEY NOTICED THE MEDICATION WAS LEAKING OUT. NO PATIENT INJURY REPORTED. NOV 30 ¿ TOWARDS THE COMPLETION OF A SUBCUTANEOUS INJECTION OF CHEMOTHERAPY (BORTEZOMIB), I NOTED A SINGLE SMALL DROP OF THE DRUG THAT LEAKED ONTO THE PATIENT'S SKIN AS I WAS SLOWLY INJECTING THE DRUG. I IMMEDIATELY STOPPED PUSHING ON THE SYRINGE PLUNGER TO PREVENT LOSS OF ANY MORE DRUG / FLUID. DEC 5 ¿ ATROPINE LEAKED OUT OF THE SYRINGE. THE NEEDLE WOULD NOT CONNECT PROPERLY WITH THE SYRINGE. DEC 12 ¿ ONE DROP OF BORTEZOMIB CAME OUT OF CONNECTION OF THE NEEDLE AND EQUASHIELD, UNABLE TO ESTIMATE HOW MUCH IN VOLUME. DEC 18 ¿ VITAMIN B12 INJECTION BEING ADMINISTERED TO PT. LOT # 2011005 25G X 5/8 NEEDLE ADAPTER (BD ECLIPSE NEEDLE) WAS USED DURING ADMINISTRATION. UPON ADMINISTRATION WRITER NOTICED MINIMAL LEAKAGE AT CONNECTION SITE BETWEEN NEEDLE ADAPTOR AND SYRINGE. ADMINISTRATION STOPPED. FEB 2 - RN WENT TO CONNECT 25G NEEDLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18803522 ↗
• MalfunctionFeb 28, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE 25X5/8 LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THEY NOTICED THE MEDICATION WAS LEAKING OUT. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. QUALITY ISSUE PRODUCT PERFORMANCE (LEAKING). WHEN THE NURSES START INJECTING MEDICATIONS, THEY NOTICED THE MEDICATION WAS LEAKING OUT. NO PATIENT INJURY REPORTED. NOV 30 ¿ TOWARDS THE COMPLETION OF A SUBCUTANEOUS INJECTION OF CHEMOTHERAPY (BORTEZOMIB), I NOTED A SINGLE SMALL DROP OF THE DRUG THAT LEAKED ONTO THE PATIENT'S SKIN AS I WAS SLOWLY INJECTING THE DRUG. I IMMEDIATELY STOPPED PUSHING ON THE SYRINGE PLUNGER TO PREVENT LOSS OF ANY MORE DRUG / FLUID. DEC 5 ¿ ATROPINE LEAKED OUT OF THE SYRINGE. THE NEEDLE WOULD NOT CONNECT PROPERLY WITH THE SYRINGE. DEC 12 ¿ ONE DROP OF BORTEZOMIB CAME OUT OF CONNECTION OF THE NEEDLE AND EQUASHIELD, UNABLE TO ESTIMATE HOW MUCH IN VOLUME. DEC 18 ¿ VITAMIN B12 INJECTION BEING ADMINISTERED TO PT. LOT # 2011005 25G X 5/8 NEEDLE ADAPTER (BD ECLIPSE NEEDLE) WAS USED DURING ADMINISTRATION. UPON ADMINISTRATION WRITER NOTICED MINIMAL LEAKAGE AT CONNECTION SITE BETWEEN NEEDLE ADAPTOR AND SYRING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18803521 ↗
• MalfunctionFeb 28, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE 25X5/8 LEAKED THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THEY NOTICED THE MEDICATION WAS LEAKING OUT. RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. QUALITY ISSUE PRODUCT PERFORMANCE (LEAKING) WHEN THE NURSES START INJECTING MEDICATIONS, THEY NOTICED THE MEDICATION WAS LEAKING OUT. NO PATIENT INJURY REPORTED. ON (B)(6) ¿ TOWARDS THE COMPLETION OF A SUBCUTANEOUS INJECTION OF CHEMOTHERAPY (BORTEZOMIB), I NOTED A SINGLE SMALL DROP OF THE DRUG THAT LEAKED ONTO THE PATIENT'S SKIN AS I WAS SLOWLY INJECTING THE DRUG. I IMMEDIATELY STOPPED PUSHING ON THE SYRINGE PLUNGER TO PREVENT LOSS OF ANY MORE DRUG / FLUID. ON (B)(6) ¿ ATROPINE LEAKED OUT OF THE SYRINGE. THE NEEDLE WOULD NOT CONNECT PROPERLY WITH THE SYRINGE. ON (B)(6) ¿ ONE DROP OF BORTEZOMIB CAME OUT OF CONNECTION OF THE NEEDLE AND EQUASHIELD, UNABLE TO ESTIMATE HOW MUCH IN VOLUME. ON (B)(6) ¿ VITAMIN B12 INJECTION BEING ADMINISTERED TO PT. LOT # 2011005 25G X 5/8 NEEDLE ADAPTER (BD ECLIPSE NEEDLE) WAS USED DURING ADMINISTRATION. UPON ADMINISTRATION WRITER NOTICED MINIMAL LEAKAGE AT CONNECTION SITE BETWEEN NEEDLE ADAPTOR AND SYRIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18803520 ↗
• MalfunctionFeb 28, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE 25X5/8 LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THEY NOTICED THE MEDICATION WAS LEAKING OUT. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. QUALITY ISSUE PRODUCT PERFORMANCE (LEAKING). WHEN THE NURSES START INJECTING MEDICATIONS, THEY NOTICED THE MEDICATION WAS LEAKING OUT. NO PATIENT INJURY REPORTED. NOV 30 ¿ TOWARDS THE COMPLETION OF A SUBCUTANEOUS INJECTION OF CHEMOTHERAPY (BORTEZOMIB), I NOTED A SINGLE SMALL DROP OF THE DRUG THAT LEAKED ONTO THE PATIENT'S SKIN AS I WAS SLOWLY INJECTING THE DRUG. I IMMEDIATELY STOPPED PUSHING ON THE SYRINGE PLUNGER TO PREVENT LOSS OF ANY MORE DRUG / FLUID. DEC 5 ¿ ATROPINE LEAKED OUT OF THE SYRINGE. THE NEEDLE WOULD NOT CONNECT PROPERLY WITH THE SYRINGE. DEC 12 ¿ ONE DROP OF BORTEZOMIB CAME OUT OF CONNECTION OF THE NEEDLE AND EQUASHIELD, UNABLE TO ESTIMATE HOW MUCH IN VOLUME. DEC 18 ¿ VITAMIN B12 INJECTION BEING ADMINISTERED TO PT. LOT # 2011005 25G X 5/8 NEEDLE ADAPTER (BD ECLIPSE NEEDLE) WAS USED DURING ADMINISTRATION. UPON ADMINISTRATION WRITER NOTICED MINIMAL LEAKAGE AT CONNECTION SITE BETWEEN NEEDLE ADAPTOR AND SYRING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18803519 ↗
• MalfunctionFeb 28, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE 25X5/8 LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THEY NOTICED THE MEDICATION WAS LEAKING OUT. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. QUALITY ISSUE PRODUCT PERFORMANCE (LEAKING). WHEN THE NURSES START INJECTING MEDICATIONS, THEY NOTICED THE MEDICATION WAS LEAKING OUT. NO PATIENT INJURY REPORTED. NOV 30 ¿ TOWARDS THE COMPLETION OF A SUBCUTANEOUS INJECTION OF CHEMOTHERAPY (BORTEZOMIB), I NOTED A SINGLE SMALL DROP OF THE DRUG THAT LEAKED ONTO THE PATIENT'S SKIN AS I WAS SLOWLY INJECTING THE DRUG. I IMMEDIATELY STOPPED PUSHING ON THE SYRINGE PLUNGER TO PREVENT LOSS OF ANY MORE DRUG / FLUID. DEC 5 ¿ ATROPINE LEAKED OUT OF THE SYRINGE. THE NEEDLE WOULD NOT CONNECT PROPERLY WITH THE SYRINGE. DEC 12 ¿ ONE DROP OF BORTEZOMIB CAME OUT OF CONNECTION OF THE NEEDLE AND EQUASHIELD, UNABLE TO ESTIMATE HOW MUCH IN VOLUME. DEC 18 ¿ VITAMIN B12 INJECTION BEING ADMINISTERED TO PT. LOT # 2011005 25G X 5/8 NEEDLE ADAPTER (BD ECLIPSE NEEDLE) WAS USED DURING ADMINISTRATION. UPON ADMINISTRATION WRITER NOTICED MINIMAL LEAKAGE AT CONNECTION SITE BETWEEN NEEDLE ADAPTOR AND SYRING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18803518 ↗