MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD PRESET¿ ECLIPSE¿; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	364390
Medical Device Problem Codes	Leak/Splash (1354); Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when using the bd preset¿ eclipse¿, blood leakage past the stopper, clotting, and blood leakage when the cap is removed was observed on an unspecified number of units.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
E1: initial reporter phone #: (b)(6).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 three photos for investigation.The evaluation of these photos showed the presence of the reported defects: clotting and leakage.Ten retained samples were functionally tested for leakage and none of the syringes leaked.Additionally, 10 retain samples were functionally tested for heparin activity and all were within specification.A review of the device history record indicated a quality notification was raised.However, lot passed all in-process and final quality checks for lot release.This complaint has been confirmed for the indicated failure modes: clotting and leakage.No definitive root cause could be established for the reported defect.Based on the low defect rate for the batch in question, no actions are planned at this time.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 when using the bd preset¿ eclipse¿, blood leakage past the stopper, clotting, and blood leakage when the cap is removed was observed on an unspecified number of units.No adverse impact was reported regarding the patient or user.

• Brand Name: BD PRESET¿ ECLIPSE¿
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: anand singh ; 1 becton drive; franklin lakes, NJ 07417 ; 2018475186
• MDR Report Key: 23744037
• Report Number: 9617032-2025-02155
• Device Sequence Number: 15568327
• Product Code: JKA
• UDI-Device Identifier: 50382903643900
• UDI-Public: (01)50382903643900(17)270331(10)5085829
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K202446
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2026

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: 364390
• Device Lot Number: 5085829
• 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: 11/12/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2025
• 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