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	04/17/2026
Type of Reportable Event	Malfunction
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 received 25 samples and 2 photos for investigation.One of the customer photos displays the device packaging, while the other photo shows several devices with blood leakage in the holder.However, needle point integrity could not be evaluated from the photos, as the safety shields are covering the iv cannula.The 25 returned samples were visually inspected for cannula defects, including needle point integrity, and all samples passed testing with no evidence of damage or poor needle point integrity.Additionally, 10 returned samples were evaluated for lube coverage, and all samples exhibited sufficient lube coverage on the iv cannula.Furthermore, 10 returned samples underwent functional tests to assess device functionality, and all samples passed testing with no evidence of side pierced sleeves, poor sleeve recovery, or sleeve leakage.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 leakage.This complaint is unable to be confirmed for the indicated failure mode: 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
It was reported while using bd vacutainer® eclipse¿ blood collection needle, an unspecified number of devices leaked blood from the np needle and caused painful venipuncture.There was no health impact or consequences reported.

• 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: 25178561
• Report Number: 1024879-2026-00761
• Device Sequence Number: 10384954
• Product Code: JKA
• UDI-Device Identifier: 30382903686095
• UDI-Public: (01)30382903686095(11)251211(17)301130(10)5345092
• 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
• Report Date (Section B): 04/21/2026

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: 5345092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2025
• 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