MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® NO ADDITIVE (Z) TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	366702
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: bd received 100 samples for investigation.Out of these, 30 returned samples were selected at random for a visual inspection, and three of these samples failed the inspection.Additionally, 30 retained samples were also subjected to a visual inspection, and none of these samples failed.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 has been confirmed for the indicated failure mode: foreign matter - unknown based on customer sample testing.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.
Event or Problem Description
It was reported while using bd vacutainer® no additive (z) tubes, particles were seen inside of an unspecified number of samples.No adverse impact was reported regarding the patient or user.

• Brand Name: BD VACUTAINER® NO ADDITIVE (Z) TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 22044618
• Report Number: 1024879-2025-00682
• Device Sequence Number: 21028056
• Product Code: FMH
• UDI-Device Identifier: 30382903667025
• UDI-Public: (01)30382903667025(11)241217(17)251130(10)4352078
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/06/2025

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 Expiration Date: 11/30/2025
• Device Catalogue Number: 366702
• Device Lot Number: 4352078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2024
• 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