MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD VACUTAINER® URINALYSIS CUP KIT; SYSTEM, TRANSPORT, AEROBIC

Model Number	364981
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Blue top urine specimen cup suction not working.

• Brand Name: BD VACUTAINER® URINALYSIS CUP KIT
• Common Device Name: SYSTEM, TRANSPORT, AEROBIC
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton dr; franklin lakes NJ 07417
• MDR Report Key: 19212717
• Report Number: 19212717
• Device Sequence Number: 6903809
• Product Code: JTW
• UDI-Device Identifier: 50382903649810
• UDI-Public: (01)50382903649810
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/09/2024
• Report Date (Section F): 02/09/2024

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: Health Professional
• Device Model Number: 364981
• Device Catalogue Number: 364981
• Device Lot Number: 3306885
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/30/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/09/2024