MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® NO ADDITIVE (Z) PLUS TUBES; CONTAINER, SPECIMEN, STERILE

Catalog Number	366408
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	12/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported prior to use of bd vacutainer® no additive (z) plus tubes, 2 tubes contained foreign matter(fm), dark brown soot was observed inside the bottom of the tubes.There was no health impact or consequences reported.
Event or Problem Description
It was reported prior to use of bd vacutainer® no additive (z) plus tubes, 2 tubes contained foreign matter(fm), dark brown soot was observed inside the bottom of the tubes.There was no health impact or consequences reported.
Additional Manufacturer Narrative
Investigation summary: bd received one photo for investigation.The analysis of the customer photo shows foreign material at the bottom of the tube.Additionally, 30 retained samples were visually inspected, and none of these samples showed any signs of foreign material.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.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® NO ADDITIVE (Z) PLUS TUBES
• Common Device Name: CONTAINER, SPECIMEN, STERILE
• 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: 21148948
• Report Number: 1024879-2024-01385
• Device Sequence Number: 9117917
• Product Code: FMH
• UDI-Device Identifier: 30382903664086
• UDI-Public: (01)30382903664086(11)240822(17)251231(10)4235330
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2025

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: 12/31/2025
• Device Catalogue Number: 366408
• Device Lot Number: 4235330
• 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: 12/17/2024
• Supplement Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/22/2024
• 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