MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® URINE COLLECTION CUPS; NON-EVACUATED URINE SPECIMEN CONTAINER IVD, NO ADDITIVE

Catalog Number	364975
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	03/07/2025
Type of Reportable Event	Serious Injury
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 after collection the bd vacutainer® urine collection cups a health care worker experienced a needle stick injury on an unspecified number of devices.It was reported it occurred after the sticker covering the cannula had been removed or in the process of removal.The health care worker underwent a body fluid exposure work-up.There were no other health consequences or impacts reported.The following information was provided by the initial reporter: we had a few accidental needlestick injuries related to cup lid.Generally, the report is about team members sticking themselves when they were moving quickly.Fingers slipped while trying to open the package.Blood and body fluid exposure work up done.No additional testing/medical intervention needed.
Additional Manufacturer Narrative
Investigation summary bd had not received samples or photographs for investigation.Neither retention samples nor 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 injury.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.
Event or Problem Description
It was reported after collection the bd vacutainer® urine collection cups a health care worker experienced a needle stick injury on an unspecified number of devices.It was reported it occurred after the sticker covering the cannula had been removed or in the process of removal.The health care worker underwent a body fluid exposure work-up.There were no other health consequences or impacts reported.The following information was provided by the initial reporter: we had a few accidental needlestick injuries related to cup lid.Generally, the report is about team members sticking themselves when they were moving quickly.Fingers slipped while trying to open the package.Blood and body fluid exposure work up done.No additional testing/medical intervention need.

• Brand Name: BD VACUTAINER® URINE COLLECTION CUPS
• Common Device Name: NON-EVACUATED URINE SPECIMEN CONTAINER IVD, NO ADDITIVE
• 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: 21950218
• Report Number: 1917413-2025-00569
• Device Sequence Number: 9056140
• Product Code: JTW
• UDI-Device Identifier: 50382903649759
• UDI-Public: (01)50382903649759
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 07/23/2025

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?: No
• 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: 04/11/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 08/19/2025
• 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