MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE; CULTURE MEDIA, NON-PROPAGATING TRANSPORT

Catalog Number	364958
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd vacutainer® boric acid sodium borate/formate c&s urine tube, an unspecified number of samples exhibit increased hematuria compared to other laboratories in the region.There was no health impact or consequences reported.
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.
Additional Manufacturer Narrative
Investigation summary: bd did not receive any samples for investigation.A visual inspection of 90 retained samples was performed, and no issues were observed.A review of the device history record for the incident lot confirmed that all product specifications and release requirements were met.The complaint could not be confirmed for the reported failure mode, erroneous results (accuracy).No definitive root cause could be identified based on the available information.Complaints associated with this device and reported condition will continue to be tracked and trended.Relevant information will be included in trend reporting and monitored by the business team, who routinely evaluates collected data for potential emerging trends.
Event or Problem Description
It was reported while using bd vacutainer® boric acid sodium borate/formate c&s urine tube, an unspecified number of samples exhibit increased hematuria compared to other laboratories in the region.There was no health impact or consequences reported.

• Brand Name: BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE
• Common Device Name: CULTURE MEDIA, NON-PROPAGATING TRANSPORT
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 23006369
• Report Number: 1917413-2025-01263
• Device Sequence Number: 10484765
• Product Code: JSM
• UDI-Device Identifier: 30382903649588
• UDI-Public: (01)30382903649588(17)260331(10)4254826
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2026

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: 03/31/2026
• Device Catalogue Number: 364958
• Device Lot Number: 4254826
• 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: 08/11/2025
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/10/2024
• 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