MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® URINE COMPLETE CUP KIT; CULTURE MEDIA, NON-PROPAGATING TRANSPORT

Catalog Number	364956
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2024
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 prior to using bd vacutainer® urine complete cup kit that eighty-six (86) kits had open and dry soap towelettes.There was no health impact or consequence reported.
Event or Problem Description
It was reported prior to using bd vacutainer® urine complete cup kit that eighty-six (86) kits had open and dry soap towelettes.There was no health impact or consequence reported.
Additional Manufacturer Narrative
Investigation summary bd received six (6) samples and three (3) photos for investigation.The analysis of the samples and photos revealed that the seam on the towelette foil pouch is open and the towelette is dry.Additionally, 10 retained samples were inspected, and one (1) kit was found to contain a towelette foil pouch with an open seam.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: open package/seal - sterility in question.Upon investigation, it was discovered that in september 2024 operators noticed during regular production that the horizontal seal on the foil pouch was not being made properly.The hub-cross seal that creates the horizontal seal had worn out causing the horizontal pressure to be incomplete.The hub-cross seal parts were replaced; towelette pouches produced after the repairs were made were inspected with zero failures.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: 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: 21064029
• Report Number: 1917413-2024-01336
• Device Sequence Number: 16998513
• Product Code: JSM
• UDI-Device Identifier: 50382903649568
• UDI-Public: (01)50382903649568(11)240709(17)260131(10)4191630
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/18/2025

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: 01/31/2026
• Device Catalogue Number: 364956
• Device Lot Number: 4191630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2024
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2024
• 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