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	12/31/2025
Type of Reportable Event	Malfunction
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.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for evaluation: yes.H.3 device eval by manufacturer? yes.D9: returned to manufacturer on: 08-jan-2026.Investigation summary: bd received 27 customer return samples and one photo for investigation.The photo was reviewed and a white powder was observed in the tubes.The photo does not confirm a sample quality issue; no photos were provided of processed samples.The 27 returned tubes were also inspected.The samples were not contained in their original polybag and eight samples were observed with unseated caps.Additionally, the tubes were also inspected and a white powder was observed in the returned samples.Furthermore, 50 retention samples were inspected and no additive abnormalities or foreign matter was observed.Complaints for sample quality are under statistical control for the month of december 2025.At this time, further testing is not indicated.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 foreign matter based on the photos and return samples.This complaint is unable to be confirmed for an additive abnormality or for sample quality (poor plasma).Bd was not able to identify a root cause for the indicated failure mode.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.Bd quality will continue to monitor foreign matter complaints.Bd quality will continue to monitor sample quality complaints.
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.No adverse impact was reported regarding the patient or user.

• 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: 24192743
• Report Number: 2618282-2026-00002
• Device Sequence Number: 9549941
• Product Code: JKA
• 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,Followup
• Report Date (Section B): 09/06/2026

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: 08/31/2026
• Device Catalogue Number: 365963
• Device Lot Number: 5062874
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2025
• Supplement Date Received by Manufacturer: 03/03/2026; Not provided
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 03/30/2026; 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2025
• 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