BD Eclipse 305767Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00382903057672), received between Apr 2, 2018 and Apr 11, 2026 — classified as 3 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (10 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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 11, 2026Break

  IT WAS REPORTED BY CUSTOMER THAT NEEDLE BROKE DURING USE. COMPLAINT VIA EMAIL. WE WERE NOTIFIED OF A COMPLAINT FROM A CUSTOMER STATING NEEDLE BROKE DURING USE. PLEASE SEE THE BELOW DETAILS REGARDING THE REPORTED ISSUE. IF IT IS INDICATED THAT A SAMPLE IS AVAILABLE, PLEASE PROVIDE SHIPPING INSTRUCTIONS WITHIN 30 DAYS OR THE SAMPLE WILL BE DISPOSED OF. MEDLINE COMPLAINT#: (B)(4), DEFECT DESCRIPTION: NEEDLE BROKE AT THE BASE DURING USE, MEDLINE PART #: 32351 PRODUCT DESCRIPTION: NDL SAFETY 25GX1.5 ECLIPSE VENDOR PART#: 305767, LOT#: 5199737, DATE REPORTED: 2/25/2026, SAMPLE RECEIVED: NO, RESPONSE NEEDED: YES, INCIDENT REPORTED TO THE FDA AS MDR-30 DAY. REFERENCE NO. 1423395-2026-00052, PLEASE REFERENCE THE ABOVE COMPLAINT NUMBER IN ALL FUTURE COMMUNICATIONS. IF YOU HAVE QUESTIONS OR NEED ADDITIONAL INFORMATION, PLEASE REACH OUT TO (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24847818 ↗
• MalfunctionFeb 19, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE 25X1-1/2 RB NEEDLE WAS CLOGGED / BLOCKED. IT WAS REPORTED BY CUSTOMER THAT NEEDLE WOULD NOT DRAW UP OR PUSH OUT WHEN ATTACHED TO THE SYRINGE. NEEDLE BLOCKED. RCC RECEIVED A COMPLAINT VIA EMAIL. NEEDLE WOULD NOT DRAW UP OR PUSH OUT WHEN ATTACHED TO THE SYRINGE. NEEDLE BLOCKED MANUFACTURER PART # 305767 LOT # 111881.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21412535 ↗
• MalfunctionFeb 13, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE 25 X 1-1/2 RB NEEDLE WAS CLOGGED/BLOCKED IT WAS REPORTED BY CUSTOMER THAT CLOGGING UP AND THE NURSES COULD NOT PUSH THE MEDICATION INTO THE PATIENT'S MUSCLE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. CLOGGING UP AND THE NURSES COULD NOT PUSH THE MEDICATION INTO THE PATIENT'S MUSCLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21378917 ↗
• MalfunctionJan 27, 2025Complete Blockage; Complete Blockage

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21243637 ↗
• MalfunctionOct 17, 2024Break; Break

  MATERIAL# 305767; BATCH# 0052504. IT WAS REPORTED BY CUSTOMER THAT NEEDLE SAFETY COVER BROKE WHEN DRAWING UP VACCINES. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. NEEDLE SAFETY COVER BROKE WHEN DRAWING UP VACCINES. PRODUCT NUMBER - 305767; LOT NUMBER - 0052504.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20478208 ↗
• MalfunctionOct 3, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE 25X1-1/2 RB LEAKED. IT WAS REPORTED BY CUSTOMER THAT DURING THE IP ADMINISTRATION THERE WAS SOME LEAKAGE FROM THE NEEDLE, AND THEY ARE UNSURE WHETHER ALL THE IP HAS BEEN ADMINISTERED TO THE SUBJECT. PER SITE: "WE CHECKED THE CONNECTIONS ETC AS THIS IS STANDARD PRACTICE. WE STRUGGLE TO SEE WHERE THE LEAKAGE WAS COMING FROM DUE TO THE SIZE OF THE NEEDLE. I WOULD NEVER INSERT THE NEEDLE COMPLETELY IN AS FOR SAFETY PURPOSES YOU NEED TO ENSURE THAT THERE IS ENOUGH TO GET HOLD OF SHOULD IT BREAK AWAY FROM THE HUB. 2/3 OF THE WAY IS NORMAL STANDARD PRACTICE. WE BOTH CHECKED THE CONNECTION WHICH IS AGAIN STANDARD PRACTICE. IT'S ALSO A BATCH WE HAVE USED BEFORE BUT THAT DOESN'T RULE OUT A PROBLEM. RCC RECEIVED A COMPLAINT VIA EMAIL. 1 ML SYRINGE 309628: LOT#: 1082594. 25G NEEDLE 305767: LOT#: 1028656. SITE MENTIONS THAT DURING THE IP ADMINISTRATION THERE WAS SOME LEAKAGE FROM THE NEEDLE, AND THEY ARE UNSURE WHETHER ALL THE IP HAS BEEN ADMINISTERED TO THE SUBJECT. PER SITE: "WE CHECKED THE CONNECTIONS ETC AS THIS IS STANDARD PRACTICE. WE STRUGGLE TO SEE WHERE THE LEAKAGE WAS COMING FROM DUE TO THE SIZE OF THE NEEDLE. I WOULD NEVER INSERT THE NEEDLE COMP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20362062 ↗
• MalfunctionAug 30, 2024Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE 25X1-1/2 RB NEEDLE CLOGGED/BLOCKED IT WAS REPORTED BY CUSTOMER THAT THEY ARE CURRENTLY HAVING A PROBLEM WITH OUR 25-GAUGE INJECTION NEEDLES. WE WILL DRAW THE SOLUTION TO BE INJECTED SWITCH NEEDLES TO THE 25-GAUGE NEEDLE WITH A SAFETY CAP. THE ISSUE THAT IS HAPPENING IS THE SOLUTION WILL NOT PUSH THRU THE NEEDLE, NO MATTER HOW HARD IT IS PUSHED. WE THEN HAVE TO SWITCH OUT THE NEEDLE AGAIN. I HAVE HAD TO STICK A PATIENT 3 TIMES BECAUSE THE 1ST 2 NEEDLES THE SOLUTION COULD NOT BE PUSHED THRU. VERBATIM: WE ARE CURRENTLY HAVING A PROBLEM WITH OUR 25-GAUGE INJECTION NEEDLES. WE WILL DRAW THE SOLUTION TO BE INJECTED SWITCH NEEDLES TO THE 25-GAUGE NEEDLE WITH A SAFETY CAP. THE ISSUE THAT IS HAPPENING IS THE SOLUTION WILL NOT PUSH THRU THE NEEDLE, NO MATTER HOW HARD IT IS PUSHED. WE THEN HAVE TO SWITCH OUT THE NEEDLE AGAIN. I HAVE HAD TO STICK A PATIENT 3 TIMES BECAUSE THE 1ST 2 NEEDLES THE SOLUTION COULD NOT BE PUSHED THRU. REF # IS 305767.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20108735 ↗
• MalfunctionJun 19, 2024Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE 25X1-1/2 RB NEEDLE WAS CLOGGED / BLOCKED. IT WAS REPORTED BY THE CUSTOMER THAT THE 25-GAUGE 1 INCH NEEDLE DID NOT HAVE A HOLE IN IT. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THE 2ND NEEDLE WAS DISCOVERED ON 5/23/24 AND THE SAFETY ZONE PORTAL INCIDENT F77576 WAS CREATED: LOT INFO: BD ECLIPSE NEEDLE, 25G 1 ½ INCH, EXP DATE 2025-09-30, LOT 0275242. WE HAVE THE ORIGINAL PACKAGING BUT NOT THE NEEDLE. WE ARE ALSO QUARANTINING ANY REMAINING NEEDLES WE HAVE FROM THIS LOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19567186 ↗
• MalfunctionApr 2, 2024Material Protrusion/Extrusion; Material Protrusion/Extrusion

  MATERIAL#: 305767, LOT#: 0237462. IT WAS REPORTED BY THE CUSTOMER THAT THE SAFETY CAME OFF WHEN CNM WENT TO USE NEEDLE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. ITEM: BD ECLIPSE 25 GUAGE NEEDLE. SAFETY CAME OFF WHEN CNM WENT TO USE NEEDLE. LOT NUMBER 0237462. 1. ARE YOU ABLE TO PROVIDE THE DATE OF EVENT IN FORMAT DD-MMM-YYYY? 08/03/2024. 2. ARE YOU ABLE TO PROVIDE THE BATCH/LOT NUMBER? 0237462. 3. WAS ISSUE BEING DESCRIBED NOTED BEFORE, OR DURING USED? DURING USE. 4. WAS THERE ANY PATIENT INVOLVEMENT? NO. 5. ANY ADVERSE EVENTS OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? NO. 7 WAS THERE ANY DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THIS EVENT? YES. NEED TO OBTAIN NEW PRODUCT, DELAYING CARE. 8. WHAT PROCEDURE WAS BEING PERFORMED? UNKNOWN. 9. WHAT MEDICATION WAS USED IN THE PROCEDURE? UNKNOWN. 10. WAS THERE ANY MEDICAL INTERVENTION DUE TO THIS EVENT? NO. 11. DOES A RETURN SHIPPING LABEL NEED TO BE GENERATED? IF YES, KINDLY PROVIDE THE SENDER¿S NAME AND ADDRESS. NO. NOTE: NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19023834 ↗
• MalfunctionMar 20, 2024Complete Blockage; Complete Blockage

  IT WAS REPORTED THE BD NEEDLE ECLIPSE 25X1-1/2 RB NEEDLE WAS CLOGGED / BLOCKED THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT WHEN INJECTING A PATIENT'S FOOT/HEEL NEEDLE (25G X 1.5 INCH) WOULD NOT INJECT MEDICATION (DEPO MEDROL AND LIDOCAINE). SHE ATTEMPTED TO READJUST THE NEEDLE AND PULL THE PLUNGER BACK SEVERAL TIMES, BUT MEDICATION WOULD NOT DELIVER. NEEDLE WITHDRAWN INTACT. NEW NEEDLE APPLIED AND INJECTION GIVEN. RESISTANCE STILL PRESENTS WITH INJECTION, BUT ABLE TO COMPLETE INJECTION. BOTH NEEDLES FROM THE SAME LOT#1274891 BD ECLIPSE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. ACCOUNT NAME: (B)(6) HOSPITAL. GPOID: H004458. COID: A1610. CONTRACT NUMBER: 687. MANUFACTURER: BD MEDICAL. DEAR VENDOR, PLEASE REVIEW AND PROVIDE A RESPONSE TO THE PRODUCT QUALITY ISSUE REPORTED. PLEASE CONTACT THE FACILITY DIRECTLY FOR DETAILS, SAMPLE COLLECTION AND RESOLUTION. WHEN THE INVESTIGATION HAS COMPLETED, PLEASE PROVIDE HEALTHTRUST WITH A COPY OF THE FINAL LETTER IN ORDER TO CLOSE OUT THE TICKET IN THE HEALTHTRUST DATABASE. I WILL FOLLOW UP WITH YOU FOR A STATUS UPDATE IN A COUPLE OF WEEKS. FACILITY CONTACT:(B)(6). DEPART

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18941303 ↗
• InjuryJun 26, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT AFTER USE WITH BD ECLIPSE¿ NEEDLE 25 G X 1 1/2 IN. SINGLE USE STERILE THE SAFETY MECHANISM DETACHED AND THE HCP RECEIVED A DIRTY NEEDLESTICK INJURY. HCP HAD BLOODWORK PERFORMED, PATIENT WILL BE GETTING BLOODWORK TESTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT WHILE ONE OF THE HCP'S WAS ENGAGING THE SAFETY ON THE ECLIPSE NEEDLE THE SAFETY FELL OFF. THE HCP WAS STUCK WITH THE NEEDLE. WHILE ONE OF THE HCP'S WAS ENGAGING THE SAFETY ON THE ECLIPSE NEEDLE THE SAFETY FELL OFF. THE HCP WAS STUCK WITH THE NEEDLE.

  Patient problems: Exposure to Body Fluids; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17199633 ↗
• MalfunctionApr 20, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED WHILE USING BD ECLIPSE¿ NEEDLE 25 G X 1 1/2 IN. SINGLE USE STERILE THE NEEDLE WAS CLOGGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INCIDENT DATE: (B)(6) 2023 HOSPITAL COMPLAINT REFERENCE #: DETAILS OF COMPLAINT (REPORTED ISSUE): THE NEEDLES OF THIS BATCH APPEAR TO BE JAMMING. ** PLEASE NOTE: THIS COMPLAINT IS BEING BROUGHT FORWARD BY THE PRODUCTS END USER. IF YOU HAVE ANY SPECIFIC QUESTIONS REGARDING THIS COMPLAINT PLEASE DIRECT THEM TO THE BELOW CONTACT. ** COMPLAINT NOTICED: DURING / AFTER USE PROBLEM FREQUENCY: 1ST TIME

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16782277 ↗
• MalfunctionSep 21, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BD ECLIPSE¿ NEEDLE FELL OFF AND UNABLE TO SAFELY SECURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE OF OUR NURSES WAS GIVING AN INJECTION USING A BD ECLIPSE NEEDLE 25G 1 ½ INCH. DURING THE INJECTION, THE SAFETY DEVICE FELL OFF AND SHE WAS UNABLE TO SAFELY SECURE THE NEEDLE POST-INJECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15460386 ↗
• MalfunctionJan 24, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED WHILE USING BD ECLIPSE¿ NEEDLE 25 G X 1 1/2 IN. SINGLE USE STERILE A NEEDLE WAS FOUND TO BE CLOGGED. THERE WERE 5 INSTANCES OF THIS. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305767. BATCH NO.: 1028656. IT WAS REPORTED THAT STAFF IS UNABLE TO PUSH MEDICATION OUT OF THE NEEDLE. RECENTLY HAD SEVERAL ISSUES (APPROX. (B)(4)) REPORTED. STAFF ARE ABLE TO EXTRACT THE MED, THEN PUSH TO DISPLACED ANY AIR BUT ONCE INJECTED INTO THE PATIENT, STAFF ARE UNABLE TO PUSH ANY FARTHER CAUSING MULTIPLE NEEDLE STICKS WHERE OTHERWISE ONLY ONE WOULD BE NEEDED. STAFF HAVE CHANGED OUT THE NEEDLE AND HAVE THEN BEEN ABLE TO PUSH THE DRUG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13333814 ↗
• InjuryOct 6, 2021Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT NEEDLE ECLIPSE 25X1-1/2 RB HAD A SAFETY MECHANISM FAILURE, CAUSING THE NURSE TO RECEIVE A NEEDLE STICK INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED IT IS TOO HARD TO COVER THE NEEDLE AND WHEN SHE LOOKED DOWN THE COVER WAS MISSING AND CAUSED A DIRTY NEEDLE STICK.

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

  MAUDE report 12586133 ↗
• MalfunctionJul 8, 2021Break; Material Protrusion/Extrusion; Break; Material Protrusion/Extrusion

  IT WAS REPORTED THAT AT LEAST ONE BD ECLIPSE¿ NEEDLE EXPERIENCED A BROKEN SAFETY MECHANISM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THEY ARE BREAKING OFF WHEN STAFF PUSHES THE PINK SAFETY PART BACK/DOWN SO THE SURGEON CAN INJECT LOCAL. IT WAS REPORTED TO ME THAT THERE IS AN ISSUE WITH THE SUBSTITUTE WE HAVE FOR ONE OF OUR HYPOS. APPARENTLY, THE SAFETY PIECE (PINK PIECE) CAN UNEXPECTEDLY BREAK OFF. I SURVEYED OTHER STAFF MEMBERS AND THEY ALL HAVE HAD THE SAME EXPERIENCE. LUCKILY, NO HARM WAS ACTUALLY DONE TO STAFF NOR PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12137353 ↗
• InjuryMar 31, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ECLIPSE¿ NEEDLE PULLED OUT OF THE HUB WHEN WITHDRAWN FROM THE CHEST WALL. IMAGING WAS REQUIRED TO LOCATE THE NEEDLE, AND IT WAS NOTED TO MOVE WITH THE PATIENT'S RESPIRATION. A WIRE WAS USED TO LOCATE THE "MOST SUPERFICIAL ASPECT" OF THE NEEDLE IN THE PECTORALIS MINOR. CT SURGERY, ICU TRIAGE, AND GENERAL SURGERY WERE CONSULTED WITH IR TO ENTER THE LEFT CHEST WALL FOR "EXPLORATION/CUTDOWN". INITIAL ATTEMPTS FAILED, BUT A VIDEO-ASSISTED THORACOSCOPIC SURGERY WAS PERFORMED AND THE NEEDLE WAS REMOVED FROM THE LUNG PARENCHYMA AND PLEURAL CAVITY. THE PATIENT RECOVERED WITHOUT COMPLICATIONS IN THE ICU. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING PORT REMOVAL, A 25-G NEEDLE USED FOR LOCAL ANESTHESIA WAS NOTED TO HAVE DETACHED FROM THE HUB UPON WITHDRAWAL FROM THE CHEST WALL. ATTEMPTS WERE MADE WITH CT TO LOCATE THE NEEDLE FOR RETRIEVAL. SOON AFTER IT WAS NOTED TO MOVE WITH RESPIRATION RAISING CONCERN FOR MTRA PULMONARY MIGRATION. A WIRE WAS USED TO LOCALIZE THE MOST SUPERFICIAL ASPECT OF THE NEEDLE IN THE PECTORALIS MINOR. CT SURGERY, ICU TRIAGE AND GENERAL SURGERY CONSULTED WITH IR TO DEVELOP A PLAN RESULTING IN GOING TO THE OR FOR LEF

  Patient problems: Foreign Body In Patient

  MAUDE report 11598914 ↗
• MalfunctionDec 11, 2020Break; Break

  IT WAS REPORTED THAT THE BD ECLIPSE¿ NEEDLE EXPERIENCED A BROKEN NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305767 BATCH NO: 0111881. PRODUCT: BD ECLIPSE INJECTION NEEDLE. NUMBER OF DEFECTIVE PRODUCT(S): 1. WHEN CONNECTED TO SYRINGE NEEDLE SNAPPED OFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10991560 ↗
• MalfunctionNov 5, 2020Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD ECLIPSE¿ NEEDLE WAS BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "STUFF NOT COMING OUT OF NEEDLE".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10793138 ↗
• MalfunctionApr 6, 2020Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE BD ECLIPSE¿ NEEDLE'S PACKAGING WAS FOUND DAMAGED AND OPENED UP DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE BD ECLIPSE NEEDLE 25G X 1 1/2 WITH LOT # 8314982 IS HAVING PACKAGE ISSUES. THE PACKAGES ARE OPENING UP SO THE INTEGRITY OF THE PRODUCT SEEMS TO BE COMPROMISED."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9929031 ↗
• MalfunctionMar 16, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT NEEDLE ECLIPSE 25X1-1/2 RB PULLED OUT OF THE HUB. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.:305767, BATCH NO.: 9227492. IT WAS REPORTED THAT THE NEEDLE FELL OUT OF THE DEVICE. PER PIR: WITH ADDITIONAL QUESTIONS ANSWERED: DID IT ONLY OCCUR ONCE? YES. DID IT RESULT IN ANY NEEDLESTICK INJURY? NO.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9836681 ↗
• MalfunctionNov 27, 2019Complete Blockage; Complete Blockage

  MATERIAL NO. 305767, BATCH NO. 9028588. IT WAS REPORTED THAT DURING USE OF THE BD ECLIPSE¿ NEEDLE THE NURSE STUCK THE PATIENT AND THE NEEDLE WOULD NOT DELIVER THE MEDICATION. THE TERM IN VERBATIM "BROKE" IS RELATED TO NEEDLE BEING CLOGGED, BECAUSE ONCE THE NEEDLE WAS CHANGED THE MEDICATION WAS DELIVERED. THIS OCCURRED ON 2 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 2 SEPARATE INCIDENTS WHERE THE NURSE STUCK THE PATIENT AND THE NEEDLE BROKE. CUSTOMER PROVIDED RESPONSE TO INFORMATION REQUESTED BUT INFORMATION WAS UNCLEAR. SENT CUSTOMER ADDITIONAL EMAIL TO CLARIFY INFORMATION. I DON'T HAVE THE DATE OF THE ADDITIONAL OCCURRENCE (IT WAS WITHIN THE LAST 6 MONTHS). THE NEEDLE DID NOT BREAK. THE MEDICATION IN THE SYRINGE COULD NOT BE PUSHED THROUGH THE LUMEN OF THE NEEDLE. THE NEEDLE HAD TO WITHDRAWN FROM THE JOINT SPACE AND A DIFFERENT NEEDLE USED TO ADMINISTER THE MEDICATION. (B)(6) 2019. CUSTOMER CALLED ME TO EXPLAIN ANSWERS TO ADDITIONAL INFORMATION REQUESTED, WAS TOLD DATE OF EVENT SHOULD NOT BE (B)(6) IT SHOULD BE (B)(6) WITH THE PATIENT IDENTIFIERS PROVIDED IN EMAIL RECVD (B)(6) SHE DID

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9386582 ↗
• MalfunctionJul 12, 2019Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT BD ECLIPSE¿ NEEDLE WAS LOOSE. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT'S NOTICED THAT SAFETY MECHANISM ON THE ECLIPSE NEEDLE LOOSEN DURING THE PREPARATION OF THE INJECTION. DEFECTED PRODUCT DIDN'T USED ON PATIENT. ONE SAMPLE FROM THE SAME BATCH WILL BE RETURNED AS SAMPLE FOR FURTHER INVESTIGATION.

  Patient problems: No Patient Involvement

  MAUDE report 8786446 ↗
• MalfunctionSep 17, 2018Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SAFETY CLIP COVERING THE BD ECLIPSE¿ NEEDLE BROKE OFF AFTER USE. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7880802 ↗
• MalfunctionApr 2, 2018Break

  IT WAS REPORTED THAT DURING USE A BD ECLIPSE ¿ NEEDLE THE NEEDLE BROKE. THE CONSUMER STATED "NEEDLE BROKE MID NEEDLE, DURING DRY NEEDLING TECHNIQUE WHERE NEEDLE WAS USED TO ENTER MUSCLE AND MOVED BACK AND FORTH AND UP AND DOWN TO RELIEVE MUSCLE SPASMS¿ THERE IS NO FURTHER INFORMATION REGARDING MEDICAL INTERVENTION REQUIRED OR INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7388916 ↗