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	12/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D.4.Medical device lot #: unknown.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.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 that following specimen collection with bd vacutainer® urine collection cups, a health care worker experienced a needle-stick injury involving 1 device while attempting to straighten a needle in the cap that appeared to be bent.It was not specified whether there was post-exposure testing or medical intervention required.There were no other health consequences or impacts reported.The following information was provided by the initial reporter: how did the needle stick incident occur: ¿phlebotomist tried several more times to fill tube and noticed needle in the cap appeared bent and tried to bend needle straight to be able to penetrate the bd vacutainer tube for collection.Phlebotomist did not realize there was a needle inside the sheath of cap and acquired a small needle stick.¿.
Additional Manufacturer Narrative
Investigation summary: bd did not receive any samples or photos for investigation.The device history records could not be reviewed as the lot number is unknown.This complaint is unable to be confirmed.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 that following specimen collection with bd vacutainer® urine collection cups, a health care worker experienced a needle-stick injury involving 1 device while attempting to straighten a needle in the cap that appeared to be bent.It was not specified whether there was post-exposure testing or medical intervention required.There were no other health consequences or impacts reported.The following information was provided by the initial reporter: how did the needle stick incident occur: ¿phlebotomist tried several more times to fill tube and noticed needle in the cap appeared bent and tried to bend needle straight to be able to penetrate the bd vacutainer tube for collection.Phlebotomist did not realize there was a needle inside the sheath of cap and acquired a small needle stick.¿.

• 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: 24027261
• Report Number: 1917413-2025-01754
• Device Sequence Number: 18441933
• Product Code: JTW
• UDI-Device Identifier: 50382903649759
• UDI-Public: (01)50382903649759
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup
• Report Date (Section B): 02/10/2026

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?: No
• Operator of Device: Health Professional
• 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: 12/11/2025
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 03/12/2026
• 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