MAUDE Adverse Event Report: BECTON DICKINSON & CO (FRANKLIN LAKES) BD VACUTAINER® EST¿ BLOOD COLLECTION TUBE; CONTAINER, SPECIMEN, STERILE

Catalog Number	362725
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while collecting blood using bd vacutainer® est¿ blood collection tube, 1 patient sample was underfilled after clotting quickly during collection.The sample was recollected.There was no health impact or consequences reported.
Additional Manufacturer Narrative
Investigation summary: bd had not received any samples or photos for investigation.A total of 20 retained samples were subjected to functional tests, and all 20 samples were found to be within specification.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.This complaint is unable to be confirmed.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.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for the identification of emerging trends.

• Brand Name: BD VACUTAINER® EST¿ BLOOD COLLECTION TUBE
• Common Device Name: CONTAINER, SPECIMEN, STERILE
• Manufacturer (Section D): BECTON DICKINSON & CO (FRANKLIN LAKES); 1 becton drive; franklin lakes NJ 07417
• 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: 24015254
• Report Number: 9617032-2025-02403
• Device Sequence Number: 10584096
• Product Code: FMH
• UDI-Device Identifier: 30382903627258
• UDI-Public: (01)30382903627258(17)261031(10)5115633
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: NA
• 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): 12/30/2025

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: 362725
• Device Lot Number: 5115633
• 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: 12/29/2025
• Initial Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/25/2025
• 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