MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® URINE COMPLETE CUP KIT; EVACUATED URINE SPECIMEN CONTAINER IVD, PRESERVATIVE

Catalog Number	364956
Medical Device Problem Codes	Off-Label Use (1494); Short Fill (1575); Inaccurate Information (4051)
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 when using the bd vacutainer® urine complete cup kit there was short fill 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 an expired tube was used.There were no health consequences or impacts reported.
Event or Problem Description
It was reported when using the bd vacutainer® urine complete cup kit there was short fill 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 an expired tube was used.There were no health consequences or impacts reported.
Additional Manufacturer Narrative
Investigation summary: bd received one photo for investigation, which shows three tubes with visible variable data on the tube label.The product has an expiry date of 28 feb 2025.The product is expired therefore no further testing was conducted.Additionally, five retained samples were visually inspected, and no issues were identified.The expiry date is consistent across the two tubes and the kit bag.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 and incorrect label information.This complaint has been confirmed for the indicated failure mode: product used after expiration date.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.

• Brand Name: BD VACUTAINER® URINE COMPLETE CUP KIT
• Common Device Name: EVACUATED URINE SPECIMEN CONTAINER IVD, PRESERVATIVE
• 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: 21883472
• Report Number: 1917413-2025-00492
• Device Sequence Number: 12737601
• Product Code: JSM
• UDI-Device Identifier: 50382903649568
• UDI-Public: (01)50382903649568(11)230731(17)250228(10)3212885
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2025

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: 02/28/2025
• Device Catalogue Number: 364956
• Device Lot Number: 3212885
• 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: 05/05/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2023
• 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