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

Catalog Number	368650
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that before using the bd vacutainer® eclipse¿ blood collection needle pre-attached holder, hub/collar separation occurred on two (2) units.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
G5: additional 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.
Additional Manufacturer Narrative
Investigation summary: bd received a photo for investigation, which shows packaging for batch 5225293 and a sample with a bent device and the hub separated from the collar.For batch 5121521, twenty retained samples were visually and functionally inspected for hub/collar separation and defective locking mechanism; all samples passed testing as the safety shields were able to be activated properly with no signs of damage or device separation.For batch 5206558, twenty retained samples were visually and functionally inspected for hub/collar separation and defective locking mechanism; all samples passed testing as the safety shields were able to be activated properly with no signs of damage or device separation.For batch 5225293, twenty retained samples were visually and functionally inspected for hub/collar separation and defective locking mechanism; all samples passed testing as the safety shields were able to be activated properly with no signs of damage or device separation.Additionally, twenty retained samples were visually inspected for bent cannula, and all samples passed testing with no signs of bent cannula.Based on a review of the device history record for the incident lots, all product specifications and requirements for lot release were met.This complaint has been confirmed for the lot 5225293, for the indicated failure modes: bent and hub/collar separation.This complaint has not been confirmed for the lot 5121521, for the indicated failure mode: hub/collar separation.This complaint has not been confirmed for the lot 5206558, for the indicated failure mode: hub/collar separation.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for the identification of emerging trends.
Event or Problem Description
It was reported that before using the bd vacutainer® eclipse¿ blood collection needle pre-attached holder, hub/collar separation occurred on two (2) units.No adverse impact was reported regarding the patient or user.

• Brand Name: BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE PRE-ATTACHED HOLDER
• 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: 23949262
• Report Number: 1024879-2025-02315
• Device Sequence Number: 10724904
• Product Code: JKA
• UDI-Device Identifier: 50382903686501
• UDI-Public: (01)50382903686501(11)250801(17)280731(10)5225293
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 04/06/2026

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: 368650
• Device Lot Number: 5225293
• 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: 12/08/2025
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2025
• 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