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BD Luer-Lok, BD Eclipse 305787Recalls & reported problems

Becton, Dickinson And Company · SYRINGE 3ML LL W/NDL ECLIPSE 25X1 RB · Class 2

Quick summary

This BD Luer-Lok syringe with an Eclipse needle is a 3 ml hypodermic syringe with a single-use safety needle, mainly used for injections such as flu vaccines. The 49 reports mostly describe leaking or splashing at the needle hub, contamination, material pushing through or sticking out, complete blockage, and parts breaking or stripping during attachment. Two reports mention injury, including needle sticks, and no deaths. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
49
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 00382903057870), received between Dec 15, 2017 and Dec 18, 2025 — classified as 2 injuries, 47 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (11 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 1 reportsFeb 2024: 1 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 2 reportsJan 2025: 1 reportsFeb 2025: 1 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 1 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Leak/Splash11
  • Device Contamination with Chemical or Other Material10
  • Material Protrusion/Extrusion8
  • Break4
  • Complete Blockage4
  • Contamination /Decontamination Problem3
  • Material Separation2
  • Contamination1

Patient problems

  • No Clinical Signs, Symptoms or Conditions25
  • No Known Impact Or Consequence To Patient12
  • No Consequences Or Impact To Patient5
  • Needle Stick/Puncture4
  • No Patient Involvement2
  • Insufficient Information1

Recent adverse event reports

The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 18, 2025Leak/Splash; Leak/Splash

    IT WAS REPORTED THAT BD SYRINGE 3ML LL W/NDL ECLIPSE 25X1 RB LEAKED IT WAS REPORTED BY CUSTOMER THAT THEY NOTED LEAKAGE FROM HUB OF NEEDLE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. (B)(6) MDIP REFERENCE NUMBER (ID): (B)(4). DATE OF INCIDENT (YYYY-MM-DD): (B)(6) 2025 SITE NAME/LOCATION: LEVEL OF HARM: (B)(6) OPTIONAL REPORT TO (B)(4): INCIDENT DETAILS: CLIENT CAME TO CLINIC FOR INFLUENZA VACCINE. DURING IMMUNIZATION TO PATIENT'S LEFT ARM AT 17:25HRS WRITER NOTED LEAKAGE FROM HUB OF NEEDLE. WRITER INFORMED (B)(6), WRITER ADVISED TO READMINISTER VACCINE AS PATIENT DID NOT RECEIVE A FULL DOSE. WRITER EXPLAINED THIS TO THE PATIENT, PATIENT AGREEABLE TO HAVE THE FLU VACCINE RE ADMINISTERED. WRITER READMINISTERED A SECOND INFLUENZA VACCINE TO RIGHT ARM AND IMMUNIZATION WAS EFFECTIVE. CLIENT UNDERSTANDING OF SITUATION. IMPACT OF INCIDENT: WHO WAS AFFECTED? PATIENT FREQUENCY OF PROBLEM: OTHER DEVICE/INCIDENT FACTORS: INVASIVE PROCEDURE? PROCEDURE: RESULTED IN A DOUBLE POKE FOR A PATIENT PHYSICIAN: DEVICE INFORMATION DEVICE NAME/DESCRIPTION: SYRINGE 3ML WITH NEEDLE SAFETY 25GA X 1 IN MANUFACTURER: BECTON DICKINSON CANADA INC MANUFACTURER CODE/MODEL: 305787 SERIAL OR L

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23842690 ↗
  • MalfunctionFeb 21, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

    NO ADDITIONAL INFORMATION

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21434309 ↗
  • MalfunctionJan 6, 2025Leak/Splash; Leak/Splash

    MATERIAL# 305787, BATCH# 4084135. IT WAS REPORTED BY CUSTOMER THAT HE IS USING ITEM 305787; LOT 4084135 AND THE PLUNGER IS SLIGHTLY BENT AND THE PLUNGER IS HARD TO PUSH. HE PUSHES THE PLUNGER HARD TO GET THE MEDICATION TO DELIVER AND THEN HE ENDS UP LOSING MEDICATION BECAUSE OF THE FORCE IT TAKES TO PUSH THE PLUNGER. HE HAS ABOUT 1/2 OF A BOX LEFT AND WOULD LIKE REPLACEMENTS. VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. CUSTOMER STATES THAT HE IS USING ITEM 305787; LOT 4084135 AND THE PLUNGER IS SLIGHTLY BENT AND THE PLUNGER IS HARD TO PUSH. HE PUSHES THE PLUNGER HARD TO GET THE MEDICATION TO DELIVER AND THEN HE ENDS UP LOSING MEDICATION BECAUSE OF THE FORCE IT TAKES TO PUSH THE PLUNGER. HE HAS ABOUT 1/2 OF A BOX LEFT AND WOULD LIKE REPLACEMENTS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21086686 ↗
  • MalfunctionDec 30, 2024Complete Blockage; Complete Blockage

    MATERIAL#: 305787, BATCH NUMBER#: 1301551. IT WAS REPORTED BY CUSTOMER THAT BATCH OF NEEDLE HAVE A LOT OF RESISTANCE VERBATIM#: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. BATCH OF NEEDLE HAVE A LOT OF RESISTANCE. REF: (B)(4). LOT: 1301551. HAS SAMPLES AVAILABLE FOR INVESTIGATION, WOULD LIKE A REPLACEMENTS FOR BOX.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21037174 ↗
  • MalfunctionDec 2, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

    NO ADDITIONAL INFORMATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20827917 ↗
  • MalfunctionFeb 16, 2024Leak/Splash; Leak/Splash

    IT WAS REPORTED THAT BD SYRINGE 3ML LL W/NDL ECLIPSE 25X1 RB LEAKED IT WAS REPORTED BY CUSTOMER THAT BD ECLIPSE SYRINGE AND NEEDLE. NEEDLE CHANGED TO BDSAFETY SLIDE 25GX1" NEEDLE. WHEN SECURING NEEDLE TO HUB OF SYRINGE, THREADS STRIPPED. NEEDLE CONTINUED TO TURN (NO EXCESSIVE FORCE USED). WHEN PHN PUSHED UP ON PLUNGER, MOST OF CONTENTS LEAKED OUT AT HUB. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. AHS MDIP REPORT. INCIDENT OR PROBLEM INFORMATION. AHS MDIP REFERENCE NUMBER (ID):(B)(4). DATE OF INCIDENT (YYYY-MM-DD): (B)(6) 2024. SITE NAME/LOCATION: (B)(4). LEVEL OF HARM: NO EFFECT - DID NOT REACH PATIENT - DETECTED BEFORE USE OR DOES NOT TOUCH PERSON DURING USE. AHS OPTIONAL REPORT TO CMDSNET (HEALTH CANADA): INCIDENT DETAILS: VACCINE DRAWN UP IN COMBO BD ECLIPSE SYRINGE AND NEEDLE. NEEDLE CHANGED TO BDSAFETY SLIDE 25GX1" NEEDLE. WHEN SECURING NEEDLE TO HUB OF SYRINGE, THREADS STRIPPED. NEEDLE CONTINUED TO TURN (NO EXCESSIVE FORCE USED). WHEN PHN PUSHED UP ON PLUNGER, MOST OF CONTENTS LEAKED OUT AT HUB. PREVIOUSLY HAVE HAD ISSUED WITH USING THESE NEEDLES ON PREFILLED VACCINES AND VACCINE LEAKING OUT AT HUB AS WELL (REPORT FILED AT THAT TIME) WHO WAS AFFECTED? NO

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18728109 ↗
  • MalfunctionJan 18, 2024Defective Component; Defective Component

    IT WAS REPORTED THAT BD SYRINGE 3ML LL W/NDL ECLIPSE 25X1 STOPPER WAS DEFECTIVE / DAMAGE / DEFORMED THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. CASE IS MANUALLY CREATED SINCE THE MANUAL ENTRY NEEDED BASED ON THE DAILY INTAKE REPORT 29 NOV 2023 (ERROR TRACKING TAB) (EMAIL WAS FORWARDED TO AEI ON 28 NOV 2023 BUT AEI FAILED TO CREATE THE CASE) THE STOPPER STICKS HALFWAY THROUGH ADMINISTERING MEDS; WAS INJECTING PATIENTS WHEN ISSUE OCCURRED; BETWEEN 3-5 AFFECTED; BOTH FEMALE AND MALE; NO ADVERSE AFFECTS. FAILURE TO DELIVER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18536844 ↗
  • MalfunctionSep 7, 2023Break; Break

    IT WAS REPORTED THAT THE SAFETY MECHANISM BROKE OFF OF THE BD LUER-LOK¿ SYRINGE WITH THE BD ECLIPSE¿ SAFETY THIN WALL NEEDLE DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "INCIDENT DETAILS: WHEN WRITER WAS PREPARING IMMUNIZATIONS IN CLINIC, WRITER OPENED A BC ECLIPSE 3ML 25G X 1 INCH NEEDLE. THE NEEDLE WAS DIFFICULT TO ATTACH TO THE SYRINGE WITHOUT IT BEING CROOKED. ONCE THE NEEDLE WAS ATTACHED TO THE SYRINGE, WRITER NEEDED TO PULL BACK THE SAFETY THAT COMES IN THE PACKAGE IN A POSITION WHERE IT IS UP AGAINST THE CAP OF THE NEEDLE. THE PROCESS OF PULLING BACK THE SAFETY CAUSED THE PLASTIC SAFETY TO POP THE CAP OFF OF THE NEEDLE ONTO THE FLOOR. WRITER DID NOT IMMEDIATELY REALIZE THAT THIS HAD HAPPENED AND ENDED UP POKING THE LEFT INDEX FINGER WITH THE STERILE NEEDLE. THE SYRINGE/NEEDLE HAD TO BE DISCARDED AND A NEW ONE OPENED FOR IMMUNIZATION USE. HAVING THE CAP POP OFF DUE TO MOVING THE SAFETY OUT OF THE WAY HAS HAPPENED SEVERAL TIMES BEFORE. IMPACT OF INCIDENT: NO HARM TO PATIENT. MINOR INJURY TO STAFF WHO WAS AFFECTED? HEALTH CARE PROFESSIONAL.. RESPONSE RECEIVED ON 9-AUG-2023. - W

    Patient problems: Needle Stick/Puncture

    MAUDE report 17706454 ↗
  • MalfunctionSep 6, 2023Break; Break

    IT WAS REPORTED THAT THE SAFETY MECHANISM BROKE OFF OF THE BD LUER-LOK¿ SYRINGE WITH THE BD ECLIPSE¿ SAFETY THIN WALL NEEDLE DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "INCIDENT DETAILS: WHEN WRITER WAS PREPARING IMMUNIZATIONS IN CLINIC, WRITER OPENED A BC ECLIPSE 3ML 25G X 1 INCH NEEDLE. THE NEEDLE WAS DIFFICULT TO ATTACH TO THE SYRINGE WITHOUT IT BEING CROOKED. ONCE THE NEEDLE WAS ATTACHED TO THE SYRINGE, WRITER NEEDED TO PULL BACK THE SAFETY THAT COMES IN THE PACKAGE IN A POSITION WHERE IT IS UP AGAINST THE CAP OF THE NEEDLE. THE PROCESS OF PULLING BACK THE SAFETY CAUSED THE PLASTIC SAFETY TO POP THE CAP OFF OF THE NEEDLE ONTO THE FLOOR. WRITER DID NOT IMMEDIATELY REALIZE THAT THIS HAD HAPPENED AND ENDED UP POKING THE LEFT INDEX FINGER WITH THE STERILE NEEDLE. THE SYRINGE/NEEDLE HAD TO BE DISCARDED AND A NEW ONE OPENED FOR IMMUNIZATION USE. HAVING THE CAP POP OFF DUE TO MOVING THE SAFETY OUT OF THE WAY HAS HAPPENED SEVERAL TIMES BEFORE. IMPACT OF INCIDENT: NO HARM TO PATIENT. MINOR INJURY TO STAFF WHO WAS AFFECTED? HEALTH CARE PROFESSIONAL... RESPONSE RECEIVED ON 9-AUG-2023. -

    Patient problems: Needle Stick/Puncture

    MAUDE report 17692636 ↗
  • MalfunctionMay 1, 2023Complete Blockage; Leak/Splash; Complete Blockage; Leak/Splash

    IT WAS REPORTED THAT THE BD ECLIPSE¿ NEEDLE WAS CLOGGED AND HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NURSE WAS ADMINISTERING THE IMMUNIZATION TO THE STUDENT AT THE SCHOOL AND AFTER INSERTING THE NEEDLE INTO THEIR DELTOID THE PLUNGER ON THE NEEDLE WOULD NOT MOVE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16844974 ↗
  • MalfunctionDec 13, 2022Material Separation; Material Separation

    IT WAS REPORTED THAT THE NEEDLE OF THE BD LUER-LOK¿ SYRINGE WITH THE BD ECLIPSE¿ SAFETY THIN WALL NEEDLE DISLODGED FROM THE INSERTION SITE AFTER THE USER HIT THE MECHANISM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WRITER WAS USING THE 3ML SYRINGE WITH THE PINK SAFETY MECHANISM TO COVER THE NEEDLE AFTER DEPLOYMENT. THE WRITER HIT THE MECHANISM AFTER INSERTING THE NEEDLE AND THE NEEDLE WAS DISLODGED FROM THE SITE. NO VACCINE WAS ADMINISTERED. IT IS FELT THIS HAPPENED DUE TO THE DESIGN OF THE NEEDLE / SAFETY DEVICE. THE PINK MECHANISM THAT IS USED TO COVER THE NEEDLE ONCE THE VACCINE IS GIVEN, STICKS OUT FROM THE SYRINGE CLOSE TO THE HUB. IT IS AWKWARD TO CHANGE THE POSITION OF THE HAND TO INJECT THE VACCINE AS THAT MECHANISM IS IN THE WAY. IMMUNIZING AN ADULT THAT DOES NOT MOVE IS EASIER AS YOU CAN TAKE THE TIME TO ADJUST YOUR HAND, BUT WITH A MOVING CHILD, IT IS MUCH MORE DIFFICULT. MANY OF THE STAFF DO NOT FEEL COMFORTABLE WITH THIS SYRINGE/NEEDLE COMBO AND DON¿T USE IT. THEY WILL USE THE 3 ML SYRINGE AND ATTACH A 1 INCH NEEDLE TO IT THAT DOES NOT HAVE THIS TYPE OF MECHANISM.".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15965902 ↗
  • MalfunctionDec 12, 2022Complete Blockage; Complete Blockage

    IT WAS REPORTED THAT 2 BD ECLIPSE¿ NEEDLE WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NURSE DREW UP VACCINE WITH COMBO SYRINGE/NEEDLE, WHEN IN CLIENT'S ARM, NURSE UNABLE TO INJECT VACCINE. NEEDLE REMOVED. THIS OCCURRED 2 TIMES TODAY WITH SYRINGE/NEEDLES FROM SAME LOT # (2 DIFFERENT NURSES) AND SAME TAKEN OUT OF USE. NO ISSUES WITH NEW LOT #.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15960515 ↗
  • MalfunctionDec 7, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

    IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE WITH THE BD ECLIPSE¿ SAFETY THIN WALL NEEDLE PLUNGER WAS DIFFICULT TO MOVE DURING THE INFLUENZA VACCINE ADMINISTRATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ONLY PARTIAL DOSE ADMINISTERED OF INFLUENZA VACCINE. REQUIRED TO GIVE A 2ND DOSE OF CORRECT INFLUENZA DOSE TO CLIENT. WRITER FELT NEEDLE PLUNGER ¿STICKING¿ WAS AN INFLUENCE IN THE ERROR."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15936687 ↗
  • MalfunctionJun 3, 2022Leak/Splash; Leak/Splash

    IT WAS REPORTED WHILE USING BD ECLIPSE¿ NEEDLE 25 G X 1 IN. WITH DETACHABLE 3 ML BD LUER-LOK¿ SYRINGE LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CONSUMER THE MEDICATION SYRINGES ARE LEAKING.   CERTAIN BD 3 ML SYRINGES ARE EITHER NOT COMPATIBLE WITH BD MAXZERO CONNECTOR OR DEFECTIVE. PHARMACY HAS RECEIVED TWO REPORTS THIS WEEK OF MEDICATION SYRINGES LEAKING DURING ADMINISTRATION AT THE SITE OF THE SYRINGE LEUR LOCK TIP:MAXZERO CONNECTION. UPON PRELIMINARY INVESTIGATION, IT IS DETERMINED THAT CERTAIN BD 3 ML SYRINGES WILL CONSISTENTLY RESULT IN LEAKAGE DURING ADMINISTRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14595113 ↗
  • MalfunctionApr 8, 2022Complete Blockage; Leak/Splash; Complete Blockage; Leak/Splash

    IT WAS REPORTED WHILE USING BD SYRINGE WITH HYPODERMIC NEEDLE ECLIPSE¿ 3 ML 25 G THE NEEDLE WAS BLOCKED AND LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT VACCINE LEAKED OUT CONNECTION BETWEEN NEEDLE AND SYRINGE. EVENT DATE: (B)(6) 2022.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14059788 ↗
  • MalfunctionOct 8, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT SYRINGE 3ML LL W/NDL ECLIPSE 25X1 RB PLUNGER CAME OFF. THIS OCCURRED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT SYRINGE WAS UNABLE TO DRAW UP LIQUID, AND THE PLUNGER CAME OFF.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12599172 ↗
  • MalfunctionAug 16, 2021Break; Material Separation; Break; Material Separation

    IT WAS REPORTED THAT THE BD ECLIPSE¿ SAFETY THIN WALL NEEDLE SEPARATED FROM THE BD LUER-LOK¿ SYRINGE AND BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BREAK A0413 - MATERIAL SEPARATION A0501 - DETACHMENT OF DEVICE OR DEVICE COMPONENT".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12328839 ↗
  • MalfunctionJul 29, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

    IT WAS REPORTED THAT THE BD ECLIPSE¿ NEEDLE EXPERIENCED THE NEEDLE PENETRATED THROUGH THE SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LOOKS LIKE THE NEEDLE HAS COME THROUGH THE CAP. NO DESCRIPTION ON WHAT HAPPENED.

    Patient problems: Insufficient Information

    MAUDE report 12250104 ↗
  • MalfunctionJul 1, 2021Material Protrusion/Extrusion; Material Protrusion/Extrusion

    IT WAS REPORTED THAT THE SAFETY MECHANISM ON THE BD LUER-LOK¿ SYRINGE WITH THE BD ECLIPSE¿ SAFETY THIN WALL NEEDLE SNAPPED OFF WHILE ATTEMPTING TO ENGAGE IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BD ECLIPSE NEEDLE, 25G, 0.5MMX25MM SAFETY MECHANISM SNAPPED OFF FROM NEEDLE HEAD WHILE I ATTEMPTED TO ENGAGE SAFETY MECHANISM WITH FOREFINGER. ALMOST PRICKED MYSELF WITH THE NEEDLE. WAS NOT ABLE TO ENGAGE SAFETY MECHANISM, THREW NEEDLE INTO SHARPS BIN.".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12103694 ↗
  • MalfunctionJun 30, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    IT WAS REPORTED THAT THE BD ECLIPSE¿ NEEDLE EXPERIENCED FOREIGN MATTER IN THE DEVICE CANNULA/NEEDLE/SYRINGE OR OTHER FLUID PATH COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305787, BATCH NO: 9234610. PHARMACIST WAS IMMUNIZING IN VACCINE CLINIC, DREW UP VACCINE DOSE FROM VIAL WITH 3 ML SYRINGE AND 5/8 NEEDLE, WENT TO CHANGE NEEDLE TO 1" BEFORE ADMINISTRATION AND NOTICED A BROWN STICKY SUBSTANCE OVER THE NEEDLE, THE SAFETY COVER AND INSIDE THE PACKAGE. VACCINE DOSE HAD TO BE WASTED BECAUSE OF THIS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12094902 ↗
  • MalfunctionJun 29, 2021Shielding Failure; Shielding Failure

    IT WAS REPORTED THAT SYRINGE 3ML LL W/NDL ECLIPSE 25X1 RB NEEDLE WENT THROUGH THE SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED NEEDLE THOUGH THE SHIELD.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12086593 ↗
  • MalfunctionJun 23, 2021Leak/Splash; Leak/Splash

    IT WAS REPORTED THAT THE BD ECLIPSE¿ NEEDLE EXPERIENCED A FAILURE TO CONTAIN BLOOD/MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:305787; BATCH NO: 9234610. CRACKS ON BD 3 ML SYRINGES, NORMAL SALINE LEAKING ON FROM CRACKS. CRACK NOTED FROM 0.5ML-2.0 ML MARKINGS ON ONE SYRINGE. CRACK NOTED FROM 0.2ML MARKING -1.4ML MARKING. CRACK NOTED FROM 0.5ML MARKING -1.5ML MARKING.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12052713 ↗
  • MalfunctionJun 23, 2021Leak/Splash; Leak/Splash

    IT WAS REPORTED THAT THE BD ECLIPSE¿ NEEDLE EXPERIENCED STOPPER SEPARATION FROM PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305787 BATCH NO: 9234610. BLACK RUBBER PIECE SEPARATED FROM PLUNGER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12052358 ↗
  • MalfunctionMay 18, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    IT WAS REPORTED THAT BLOOD-LIKE FOREIGN MATTER WAS SEEN ON THE BD LUER-LOK¿ SYRINGE WITH BD ECLIPSE¿ SAFETY THIN WALL NEEDLE INSIDE THE SEALED PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "STAFF AT THE COVID VACCINATION CLINIC GRABBED A 3ML SYRINGE/NEEDLE COMBO PACK TO USE AND NOTED THERE WAS WHAT LOOKED LIKE BLOOD ON THE LUER END OF THE NEEDLE. THE PACKAGE WAS SEALED AND REMAINS SEALED."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11845995 ↗
  • MalfunctionMay 17, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    IT WAS REPORTED THAT SYRINGE 3ML LL W/NDL ECLIPSE 25X1 RB HAD FOREIGN MATTER. THIS OCCURRED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305787 BATCH NO: UNKNOWN. IT WAS REPORTED THAT TWO SYRINGES HAD CRYSTALS OR SOMETHING ON THE NEEDLE. VERBATIM: WE HAD ANOTHER SYRINGE ISSUE. THE STAFF AT OUR OUTPATIENT CLINIC FOUND TWO SYRINGES THAT LOOK LIKE THEY HAVE SOME TYPE OF CRYSTALS OR SOMETHING ON THE NEEDLE. THEY ARE THE BD ECLIPSE 3ML 25G X1. WE DO NOT KNOW THE LOT NUMBER. NO OTHER ISSUES WITH ANY OF THE OTHER SYRINGES HAVE BEEN NOTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11838891 ↗

Other Needle, hypodermic, single lumen devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.