BD Eclipse 305765Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00382903057658), received between Jan 29, 2019 and Sep 28, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Packaging Problem” (7 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Packaging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923617 ↗
• MalfunctionJul 15, 2025Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE 21X1-1/2 RB TW PACKAGE DAMAGED / DEFECTIVE IT WAS REPORTED BY THE CUSTOMER THAT A TEAR IN THE PAPER TYVEK BACKING OF A NEEDLE POUCH WAS DETECTED DURING PACKAGING OPERATIONS. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. DURING PACKAGING OPERATIONS, ONE NEEDLE POUCH WAS DETECTED WITH A TEAR IN THE PAPER TYVEK BACKING. THE TEAR WAS MINISCULE AND OBSERVED BY THE AQL INSPECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22509255 ↗
• MalfunctionMar 24, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE 21X1-1/2 RB HAD FOREIGN MATTER DURING THE PRODUCTION PROCESS, A DIRTY CANNULA WITH BLACK PARTICLES WAS DISCOVERED, PLEASE SEE THE FOLLOWING PICTURES. THIS CONCERNS YOUR BATCH 4126045. TO FACILITATE OUR INTERNAL EVALUATION, WE KINDLY REQUEST INFORMATION REGARDING YOUR AWARENESS OF THIS DEFECT AND WHETHER ANY SIMILAR ANALYSES OR POTENTIAL CAUSES HAVE BEEN INVESTIGATED IN THE PAST. PLEASE NOTE THAT THIS IS AN ENQUIRY AND NOT AN OFFICIAL COMPLAINT. CAN YOU TELL US THE DATE OF THE INCIDENT? ARE SAMPLES AVAILABLE FOR EXAMINATION? IF SO, WHERE AND FROM WHOM CAN WE HAVE IT COLLECTED? ADDRESS, TELEPHONE NUMBER AND E-MAIL ADDRESS ARE REQUIRED. THE DATE OF THE INCIDENT WAS (B)(6) 2025. SINCE THIS IS ONLY A SINGLE SAMPLE, WE WILL BE HAPPY TO SEND IT TO YOU. COULD YOU GIVE ME THE CORRESPONDING ADDRESS? PLEASE SEND THE SAMPLE TO: BD GMBH MARTIN ERTL TULLASTR. 8 -12 69126 HEIDELBERG. COULD YOU PLEASE CHECK WHETHER THE SAMPLE WE SENT HAS ARRIVED AT YOUR DOORSTEP? THE ATTACHED INVESTIGATION REPORT WAS PREPARED WITHOUT THE SAMPLE AND DOES NOT CONTAIN ANY STATEMENTS ABOUT THE CONTAMINATION. YES, THE PATTERN HAS ARRIVED AT ME. THE REPORT IS ADJUSTED AGAIN AND THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21682399 ↗
• MalfunctionFeb 18, 2025Contamination; Contamination

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE 21X1-1/2 RB TW HAD FOREIGN MATTER DURING THE PRODUCTION PROCESS, A DIRTY CANNULA WITH BLACK PARTICLES WAS DISCOVERED, PLEASE SEE THE FOLLOWING PICTURES. THIS CONCERNS YOUR BATCH 4126045. TO FACILITATE OUR INTERNAL EVALUATION, WE KINDLY REQUEST INFORMATION REGARDING YOUR AWARENESS OF THIS DEFECT AND WHETHER ANY SIMILAR ANALYSES OR POTENTIAL CAUSES HAVE BEEN INVESTIGATED IN THE PAST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21405380 ↗
• MalfunctionAug 7, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE 21X1-1/2 RB NEEDLE BROKE. IT WAS REPORTED BY CUSTOMER THAT THE INCIDENT WITH AN ECLIPSE 21G 1 1/2 LOT NEEDLE 1362829 EXP 2026-12-31 THAT OCCURRED AT OUR CLINIC YESTERDAY DURING THE INJECTION OF A MEDICATION TO ONE OF OUR PATIENTS. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. I WOULD LIKE TO REPORT AN INCIDENT WITH AN ECLIPSE 21G 1 1/2 LOT NEEDLE 1362829 EXP 2026-12-31 THAT OCCURRED AT OUR CLINIC YESTERDAY DURING THE INJECTION OF A MEDICATION TO ONE OF OUR PATIENTS. UNFORTUNATELY, THE DEFECTIVE NEEDLE WAS THROWN INTO THE NEEDLE CONTAINER. IT WAS IMPOSSIBLE TO GET IT BACK. PRODUCT NUMBER - 305765. CUSTOMER RESPONSE RECEIVED ON 18-JUN-2024. THE TRANSLATION OF THE CUSTOMER RESPONSE IS: 1. COULD YOU PROVIDE US WITH THE EXACT DATE OF THE INCIDENT (IN DD-MM-YYYY FORMAT)? (B)(6) 2024. 2. PLEASE DESCRIBE ANY PATIENT INJURY, INJURY, COMPLICATION OR ADVERSE CONSEQUENCE OF THE INCIDENT. PATIENT DID NOT RECEIVE FULL DOSE OF ANTIBIOTIC. CUSTOMER RESPONSE RECEIVED ON 16-JUL-2024. 1. WHAT WAS THE FLAW? DURING THE INTRAMUSCULAR INJECTION INTO THE PATIENT, THE NEEDLE DETACHED FROM THE SYRINGE. THE NURSE OBSERVED THE BREAKAGE OF THE EQUIPMENT AT THE NEEDLE THRE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19932337 ↗
• MalfunctionJul 16, 2024Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT BD NEEDLE ECLIPSE 21X1-1/2 RB TW PACKAGE DAMAGED/ DEFECTIVE. IT WAS REPORTED BY CUSTOMER THAT ONE NEEDLE POUCH WAS DETECTED WITH A TEAR IN THE PAPER TYVEK BACKING. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. DURING PACKAGING OPERATIONS, ONE NEEDLE POUCH WAS DETECTED WITH A TEAR IN THE PAPER TYVEK BACKING. THE TEAR WAS MINISCULE AND OBSERVED BY THE AQL INSPECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19751961 ↗
• MalfunctionDec 22, 2022Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE BD ECLIPSE¿ NEEDLE PACKAGING HAD TINY TEARS WHICH EXPOSED THE NEEDLE OUTSIDE THE ENVIRONMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING THE PACKAGING PROCESS, IT WAS IDENTIFIED BY THE OPERATORS THAT THE TYVEK SIDE OF THE NEEDLE PACKAGING HAD TINY TEARS WHICH EXPOSED THE NEEDLE TO THE OUTSIDE ENVIRONMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16032009 ↗
• MalfunctionMay 13, 2021Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT NEEDLE ECLIPSE 21X1-1/2 RB TW HAD A SAFETY MECHANISM FAILURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:305765 BATCH NO: 0090373   IT WAS REPORTED THAT DURING PACKAGING, A FIVE PACK OF 21G NEEDLES WAS FOUND TO BE MISSING THE COMPLETE NEEDLE IN ONE PACKET AND THE NEEDLE WAS MISSING THE SAFETY SHIELD IN A SECOND PACKET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11822966 ↗
• MalfunctionJul 7, 2020Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE BD ECLIPSE¿ NEEDLE SAFETY SHIELD WAS FOUND DETACHED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE CONTINUE TO FIND UNACCEPTABLE UNITS (MISSING SAFETY SHIELD) IN LOT NUMBER 8171369."

  Patient problems: No Patient Involvement

  MAUDE report 10243051 ↗
• MalfunctionJun 2, 2020Packaging Problem

  IT WAS REPORTED THAT NEEDLE ECLIPSE 21X1-1/2 RB TW CANNULA AND THE SAFETY SHIELD WERE PROTRUDING THROUGH THE PACKAGE. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305765 BATCH NO.:8171369 IT WAS REPORTED WHEN THE CUSTOMER RESPONDED TO AN INFORMATION REQUEST FOR A PREVIOUS COMPLAINT THEY STATED THEY ALSO HAD PRODUCT THAT HAD THE NEEDLE AND SAFETY SHIELD PROTRUDING OUT OF THE PACKAGE.

  Patient problems: No Patient Involvement

  MAUDE report 10112282 ↗
• MalfunctionApr 21, 2020Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF NEEDLES ECLIPSE 21X1-1/2 RB TW EXPERIENCED DAMAGED OR OPEN UNIT PACKAGING/SEAL WHERE STERILITY WAS COMPROMISED. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305765 BATCH NO.: 8171369, UNKNOWN WE RECEIVED 801,600 NEEDLES OF LOT 8171369. OUR PACKAGING LOTS ARE AROUND 100K , AND WE HAVE SEEN THIS DEFECT IN MORE THAN ONE LOT. NOT A LARGE NUMBER, WE DON'T KEEP TRACK OF HOW MANY. NO IMPACT, EASY TO SORT OUT. WE HAVE NOT BEEN CAPTURING THE NUMBER OF THE OTHER PACKAGING LOT DEFECTS. THE NUMBERS ARE SMALL, I WAS JUST LETTING YOU KNOW WE ARE STILL SEEING THE DEFECT. WE WILL IN THE FUTURE PROVIDE YOU FIRM NUMBERS FOR ANY DEFECTS WE FIND ON LINE. DAMAGED NEEDLE PACKS OPENED. DURING THE PACKAGING CL0537 ON (B)(6) 2020, NEEDLE 21 GAUGE 1 1/2" BD ECLIPSE (VENDOR LOT 8171369) 5 NEEDLE SLEEVES WERE NOTED TO HAVE DAMAGE TO THE NEEDLE AND THE TYVEK POUCH WAS OPENED. THE DEFECT IS SUCH THAT IT QUESTIONS THE STERILITY OF THE PRODUCT RECEIVED FROM BD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9983250 ↗
• MalfunctionFeb 12, 2020Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE BD NEEDLE ECLIPSE 21X1-1/2 RB TW PRIOR TO USE PACKAGING WAS DAMAGED AND AFFECTED STERILITY OF NEEDLE. THERE WERE 15 DIFFERENT OCCURENCES. ¿MATERIAL NO.: 305765, BATCH NO.: 8171369. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: DAMAGED NEEDLE PACKS OPENED. DURING THE PACKAGING (B)(4) ON (B)(6) 2020, NEEDLE 21 GAUGE 1 1/2" BD ECLIPSE 5 NEEDLE SLEEVES WERE NOTED TO HAVE DAMAGE TO THE NEEDLE AND THE TYVEK POUCH WAS OPENED. THE DEFECT IS SUCH THAT IT QUESTIONS THE STERILITY OF THE PRODUCT RECEIVED FROM BD. REQUESTS A FORMAL BD INVESTIGATION INTO THIS DEFECT.¿

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9700199 ↗
• MalfunctionNov 27, 2019Material Protrusion/Extrusion; Material Protrusion/Extrusion

  MATERIAL NO.: 305765, BATCH NO.: 8052419. 1 OF 2. IT WAS REPORTED THAT THE NEEDLE ECLIPSE 21X1-1/2 RB TW THE SAFETY DEVICE FELL OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I HAVE TWO SAMPLES IN MY OFFICE WHERE THE SAFETY DEVICE HAS FALLEN OFF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9385272 ↗
• MalfunctionJun 11, 2019Illegible Information; Illegible Information

  IT WAS REPORTED THAT ILLEGIBLE LABEL PRINT WAS OBSERVED ON THE BD ECLIPSE¿ NEEDLE BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DURING INCOMING INSPECTION OF LOT 9028581 WE OBSERVED PRIMARY PACKS WHERE THE VARIABLE LOT DATA IS NOT PRINTED TOTALLY READABLE: INSPECTED NUMBER N=80. WITHIN THE INSPECTED RANDOM SAMPLES (N=80) WE FOUND FIVE AFFECTED BLOCKS OF BLISTER STRIPS. AT TWO OF FIVE BLISTERS THE LOT NUMBER (9028581: SECOND 8 BECOMES 3) IS NOT READABLE/UNCLEAR (ALTOGETHER 16 WITHIN N=80)."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8687660 ↗
• MalfunctionMay 16, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT COURSE, BLACK FOREIGN MATTER, AND SMEARED, BROWN FOREIGN MATTER WERE FOUND ON 3 NEEDLE ECLIPSE 21X1-1/2 RB TW SLEEVES AND ONE POUCH DURING THE PACKAGING PROCESS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ON (B)(6) 2019, SEVERAL NEEDLE SLEEVES FROM VENDOR LOT 7326068 WAS FOUND WITH FOREIGN MATERIAL ON THE OUTSIDE. THIS DEFECT WAS DISCOVERED DURING THE PACKAGING PROCESS BY AN OPERATOR FOR LOT AJ8696. THE FOREIGN MATERIAL HAS TWO APPEARANCE OF BLACK AND BROWN. THE BLACK FOREIGN MATERIAL WAS A SINGLE MARK ON MULTIPLE SLEEVES AND WAS NOTED TO BE COURSE/TACKY. THE BROWN FOREIGN MATERIAL WAS ON A SINGLE SLEEVE AND SMEARED/SATURATED ACROSS THE LENGTH OF THE POUCH."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8615728 ↗
• MalfunctionJan 29, 2019Fail-Safe Did Not Operate

  IT WAS REPORTED THAT BD¿ NEEDLE ECLIPSE 21X1-1/2 RB TW HAD A SAFETY FAILURE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8286405 ↗