MAUDE Adverse Event Report: BECTON DICKINSON & CO (FRANKLIN LAKES) BD VACUTAINER® C&S PRESERVATIVE URINE TUBE; CULTURE MEDIA, NON-PROPAGATING TRANSPORT

Catalog Number	364951
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
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 that prior to using bd vacutainer® c&s preservative urine tube, an incorrect expiration date appeared on an unspecified number of packages.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
After further review of the complaint details and the applicable regulatory requirements of the republic of colombia, it has been determined that mdr report 1917413-2026-00289 was submitted in error.As the event does not meet reportability criteria, the mdr submission was not required.Please disregard mdr report 1917413-2026-00289.
Event or Problem Description
It was reported that prior to using bd vacutainer® c&s preservative urine tube, an incorrect expiration date appeared on an unspecified number of packages.No adverse impact was reported regarding the patient or user.Update: per additional information received from the region, there is no compliance issue related to the labeling.This event does not meet the definition of a complaint and will be closed accordingly.

• Brand Name: BD VACUTAINER® C&S PRESERVATIVE URINE TUBE
• Common Device Name: CULTURE MEDIA, NON-PROPAGATING TRANSPORT
• 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 ; 2018475186
• MDR Report Key: 24879095
• Report Number: 1917413-2026-00289
• Device Sequence Number: 8951562
• Product Code: JSM
• UDI-Device Identifier: 30382903649519
• UDI-Public: (01)30382903649519(10)364951
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K024240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2026

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: 364951
• Device Lot Number: 5188938
• 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: 03/16/2026
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 04/14/2026
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/07/2025
• 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