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

Catalog Number	364975
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
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 that the shipping box of bd vacutainer® urine collection cups depicted two labels with two different lot numbers.The number of occurrences is unspecified.No adverse impact was reported regarding the patient or user.
Event or Problem Description
It was reported that the shipping box of bd vacutainer® urine collection cups depicted two labels with two different lot numbers.The number of occurrences is unspecified.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
Investigation summary bd had not received samples, but one (1) photo was provided for investigation.The photo was evaluated confirming an incorrect case label was applied for catalog 364975 with lot number 4247203 instead of lot 4247201.The shipping label is correct and contains all the correct information.The case label has the incorrect lot number in both the human readable portion of the label and the barcode.The printed expiration date is not affected by this discrepancy.No retentions are kept for this product.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 been confirmed for the indicated failure mode incorrect label content based on customer provided photos.Bd determined that the root cause of the indicated failure mode was attributed to manual error that occurred during manufacturing.A situation analysis was opened and based on an evaluation of frequency and severity it was determined that no corrective action is required at this time complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD VACUTAINER® URINE COLLECTION CUPS
• 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: 21359782
• Report Number: 1917413-2025-00100
• Device Sequence Number: 15571887
• Product Code: JTW
• UDI-Device Identifier: 50382903649759
• UDI-Public: (01)50382903649759(11)240903(17)260930(10)4247201
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 02/28/2025

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: 09/30/2026
• Device Catalogue Number: 364975
• Device Lot Number: 4247201
• 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: 01/16/2025
• Supplement Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/03/2024
• 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