MAUDE Adverse Event Report: Becton Dickinson & CO (Franklin Lakes) BD Vacutainer® Urine Analysis Preservative Tube; CONTAINER, SPECIMEN, STERILE

Catalog Number	364992
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	08/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd vacutainer® urine analysis preservative tube, the urine analyzer triggered the ¿check for crystals¿ alarm; however, upon reviewing the captured images, no crystals were visible, only black streaks.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
Investigation summary: bd received one photo for investigation.Upon evaluation, the photo did not reveal the failure mode indicated by the customer.Additionally, a visual inspection was conducted on 100 retained samples, and no issues were identified.The device history records were reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.This complaint has not been confirmed for the indicated failure mode: foreign matter inside product / fluid path.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.Our business team regularly reviews the collected data for the identification of emerging trends.

• Brand Name: BD Vacutainer® Urine Analysis Preservative 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 & CO. (Broken Bow); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: anand singh ; 1 becton drive; franklin lakes, NJ 07417 ; +1(201)847-5186
• MDR Report Key: 50900115
• Report Number: 1917413-2026-00898
• Device Sequence Number: 12271393
• Product Code: FMH
• UDI-Device Identifier: 30382903649922
• UDI-Public: (01)30382903649922(17)270731(10)6013692
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: N/A
• 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): 09/07/2026

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 Catalogue Number: 364992
• Device Lot Number: 6013692
• 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: 08/27/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2026
• 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