MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® URINE COMPLETE CUP KIT; SYSTEM, TRANSPORT, AEROBIC

Catalog Number	364957
Medical Device Problem Codes	Off-Label Use (1494); Short Fill (1575); Expiration Date Error (2528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported while using bd vacutainer® urine complete cup kit, underfill was observed in an unspecified number of devices.It was then discovered that the expiration date on the shelf label was beyond the expiration date of the tube.The expiration date on the tube label had already passed so expired tubes were used.There were no health consequences or impacts reported.
Additional Manufacturer Narrative
Investigation summary: bd had not received any samples for investigation.10 retentions were visually inspected with no issues being identified.A total of 5 retention samples had functional draw testing performed on both tube components.All tubes were within specification limits with no issues identified.The expiration date on the two tube components is the same as on the kit: 31may2026.No date discrepancy was observed.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.This complaint has not been confirmed for the indicated failure modes: underfill, incorrect/missing label information, expired product.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.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for the identification of emerging trends.
Event or Problem Description
It was reported while using bd vacutainer® urine complete cup kit, underfill was observed in an unspecified number of devices.It was then discovered that the expiration date on the shelf label was beyond the expiration date of the tube.The expiration date on the tube label had already passed so expired tubes were used.There were no health consequences or impacts reported.

• Brand Name: BD VACUTAINER® URINE COMPLETE CUP KIT
• Common Device Name: SYSTEM, TRANSPORT, AEROBIC
• 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: 21913518
• Report Number: 1917413-2025-00524
• Device Sequence Number: 17951448
• Product Code: JTW
• UDI-Device Identifier: 00382903649570
• UDI-Public: (01)00382903649570(11)241106(17)260531(10)4311347
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• 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): 05/29/2025

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: 364957
• Device Lot Number: 4311347
• 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: 03/28/2025
• Supplement Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/06/2024
• 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