MAUDE Adverse Event Report: BECTON DICKINSON & CO (FRANKLIN LAKES) BD MICROTAINER® Z (NO ADDITIVE TUBES); TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number	365963
Medical Device Problem Code	Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd microtainer® z (no additive tubes), an unspecified number of tubes exhibited additive abnormality presenting as white material.Additionally, the blood of an unspecified number of tubes did not separate when spun, it turned brown and granular.Recollection was necessary.Five tubes were affected; however, it was unspecified which sample presented which defect.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd microtainer® z (no additive tubes), an unspecified number of tubes exhibited additive abnormality presenting as white material.Additionally, the blood of an unspecified number of tubes did not separate when spun, it turned brown and granular.Recollection was necessary.Five tubes were affected; however, it was unspecified which sample presented which defect.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9: device available for evaluation: yes.D9: returned to manufacturer on: 08-jan-2026.H.3 device eval by manufacturer? yes.Investigation summary: bd received 15 samples and one photo for investigation.The photo was reviewed and shows 2 tubes with white powder inside them.The samples were not contained in their original polybag, and two samples were observed with unseated caps.A white powder was also observed inside the tubes.Additionally, 50 retain samples were evaluated for visual presence of dry additive and foreign matter with acceptable results.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint is confirmed for the indicated failure mode foreign matter.Bd was not able to identify a root cause for the indicated failure mode.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.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD MICROTAINER® Z (NO ADDITIVE TUBES)
• 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): BD CARIBE LTD.; road 31; k.m. 24.3; juncos PR
• Manufacturer Contact: anand singh ; 1 becton drive; franklin lakes, NJ 07417 ; 2018475186
• MDR Report Key: 24027701
• Report Number: 2618282-2025-00153
• Device Sequence Number: 8939675
• Product Code: JKA
• UDI-Device Identifier: 30382903659631
• UDI-Public: (01)30382903659631(17)260531(10)4337968
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K991702
• 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,Followup
• Report Date (Section B): 03/17/2026

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 Expiration Date: 05/31/2026
• Device Catalogue Number: 365963
• Device Lot Number: 4337968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 04/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2024
• 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