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

Catalog Number	364975
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	02/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after using bd vacutainer® urine collection cups, a healthcare professional received a dirty needlestick injury to the left index finger when attempting to place a sticker over the inoculating port.Employee was later seen at the emergency room.No report of post exposure testing or medical intervention was provided.
Additional Manufacturer Narrative
B3: date of event is unknown.The date received by manufacturer has been used for this field.D4.Medical device expiration date: unknown.H4.Device manufacture date: unknown.Investigation summary: bd had not received any samples or photos for investigation.The device history records could not be reviewed as the lot number is unknown.This complaint has not been confirmed for the indicated failure mode: needle stick.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 COLLECTION CUPS
• Common Device Name: SYSTEM, TRANSPORT, AEROBIC
• Manufacturer (Section D): BECTON DICKINSON & CO (FRANKLIN LAKES); 1 becton drive; franklin lakes NJ 07417
• 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: 24688237
• Report Number: 1917413-2026-00194
• Device Sequence Number: 10004661
• Product Code: JTW
• UDI-Device Identifier: 50382903649759
• UDI-Public: (01)50382903649759
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• 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): 03/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 364975
• Device Lot Number: UNKNOWN
• 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: 02/25/2026
• Initial Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown