MAUDE Adverse Event Report: Becton Dickinson & CO (Franklin Lakes) BD Vacutainer® Eclipse¿ Blood Collection Needle; Tubes, vials, systems, serum separators, blood collection

Catalog Number	368607
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following fields were updated due to additional information:\ d.9: device available for evaluation: yes\ h.3: device eval by manufacturer? yes\ d.9: returned to manufacturer on: 01-oct-2026\ h.1 imdrf annex a grid (1): a040102 - loss of or failure to bond (1068)\ \ investigation summary:\ bd received 10 samples and 4 photos for investigation.The ten returned samples were subjected to a visual functional test for defective locking mechanism and hub/collar separation.All samples passed testing, as there were no signs of damage to the device or separation during activation of the safety shield.Additionally, four customer photos were received, with one indicating batch details on the shelf carton and three images indicating hub/collar separation.\ device history record review confirmed that product quality was evaluated during manufacturing with prescribed inspections, all of which were in compliance with requirements.No related quality notifications or nonconformance reports were associated.\ this complaint has been confirmed for the indicated failure mode: hub/collar separation.\ no definitive root cause could be established for the reported defect.\ complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for the identification of emerging trends.
Event or Problem Description
Report 3 of 4\ \ it was reported that when using the bd vacutainer® eclipse¿ blood collection needle, an unspecified number of units exhibited hub/collar separation when attaching the holder or when attempting to activate the safety mechanism.No adverse impact was reported regarding the patient or user.

• Brand Name: BD Vacutainer® Eclipse¿ Blood Collection Needle
• Common Device Name: Tubes, vials, systems, serum separators, blood collection
• Manufacturer (Section D): Becton Dickinson & CO (Franklin Lakes); 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: anand singh ; 1 becton drive; franklin lakes, NJ 07417 ; +1(201)847-5186
• MDR Report Key: 50923621
• Report Number: 1024879-2026-01688
• Device Sequence Number: 5545011
• Product Code: JKA
• UDI-Device Identifier: 30382903686071
• UDI-Public: (01)30382903686071(11)250527(17)300430(10)5147661
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K243207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 368607
• Device Lot Number: 5147661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/27/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown