MAUDE Adverse Event Report: BECTON DICKINSON & CO (FRANKLIN LAKES) BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number	368609
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event is unknown.The date received by manufacturer has been used for this field.There were multiple 510k numbers reported to be involved.The information is as follows: g.4.Pma / 510(k)#: k982541.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
Report 15 of 15: it was reported while using bd vacutainer® eclipse¿ blood collection needle, blood leaked from the non-patient end of the device after filling the tube with one patient.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
Bd received 48 samples, 1 video, and 2 photos for investigation.The customer provided 2 photos showing the device packaging, but these did not display the reported defects.Additionally, the video submitted by the customer demonstrated a device being used for a blood draw, with blood observed inside the holder and on the cap of the connected tube; however, needle point integrity could not be assessed because the cannula was not visible.Twenty of the customer samples were randomly selected and subjected to a visual inspection for all cannula defects, including needle point integrity.All samples passed testing with no evidence of damage to the cannula or poor needle point integrity.In addition, 10 of the customer samples were subjected to a test for lube coverage.All samples passed testing exhibiting sufficient lube coverage on the iv cannula.Furthermore, 10 of the customer samples were subjected to sleeve function testing using 10 tubes per needle to assess functionality of the device.All the samples passed testing exhibiting no evidence of side pierced sleeves, poor sleeve recovery, or sleeve leakage during the draw.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint has been confirmed for the indicated failure mode sleeve function based on the video provided.This complaint is unable to be confirmed for needle point integrity.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
Report 15 of 15: it was reported while using bd vacutainer® eclipse¿ blood collection needle, blood leaked from the non-patient end of the device after filling the tube with one patient.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 ; 2018475186
• MDR Report Key: 25035379
• Report Number: 1024879-2026-00671
• Device Sequence Number: 21126073
• Product Code: JKA
• UDI-Device Identifier: 30382903686095
• UDI-Public: (01)30382903686095(11)260115(17)301231(10)6015483
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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,Followup
• Report Date (Section B): 05/07/2026

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: 368609
• Device Lot Number: 6015483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2026
• Supplement Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2026
• 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