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

Catalog Number	368608
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd vacutainer® eclipse¿ blood collection needle, blood leakage from the rubber sleeve occurred with an unspecified number of devices.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
There were multiple 510k numbers reported to be involved.The information is as follows: g.4.Pma/510(k)#: k982541.Investigation summary: bd did not receive any samples or photos for investigation.A review of the device history record was completed.Product quality is evaluated during the manufacturing process with prescribed variable and attributes inspections.All inspections were in compliance with requirements.There were no quality notifications or nonconformance material reports associated with this batch.This complaint has not been confirmed for the indicated failure mode: sleeve function.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.

• 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: 50870512
• Report Number: 1024879-2026-01674
• Device Sequence Number: 21511830
• Product Code: JKA
• UDI-Device Identifier: 30382903686088
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/29/2026

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: 368608
• Device Lot Number: 5275021
• 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: 08/25/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/02/2025
• 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