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	Microbial Contamination of Device (2303); Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during use of bd vacutainer® urine complete cup kit, 15 tubes are contaminated.They are seeing mixed growth in cultures.In addition, the additive looks like condensation.Samples were recollected.There was no other health impact or consequences reported.
Additional Manufacturer Narrative
Investigation summary: bd received 11 samples and 2 photos for investigation.The visual inspection of the returned samples did not show any foreign matter or additive abnormality.The evaluation of the photos show product packaging and a tube with spray coated additive on the side wall of the tube.The additive for this product is a normal appearance and applied per specification.The product was sterilized per specification.No issues were seen with the photo returned by the customer.The samples and photos do not show the customer's indicated failure modes.Additionally, 10 retained samples were visually inspected with no issues being identified.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.A compliant history revealed no other complaints have been received for this lot for these failure modes.This complaint has not been confirmed for the indicated failure modes: additive abnormality and foreign matter - biological.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: 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: anand singh ; 1 becton drive; franklin lakes, NJ 07417 ; 2018475186
• MDR Report Key: 23511632
• Report Number: 1917413-2025-01517
• Device Sequence Number: 9666691
• Product Code: JTW
• UDI-Device Identifier: 00382903649570
• UDI-Public: (01)00382903649570(17)261130(10)5134593
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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
• Report Date (Section B): 10/16/2025

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 Catalogue Number: 364957
• Device Lot Number: 5134593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2025
• 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