MAUDE Adverse Event Report: Becton Dickinson & CO (Franklin Lakes) BD Vacutainer® Safety-Lok¿ Blood Collection Set; Tubes, vials, systems, serum separators, blood collection

Catalog Number	367281
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2026
Type of Reportable Event	Malfunction

• Brand Name: BD Vacutainer® Safety-Lok¿ Blood Collection Set
• Common Device Name: Tubes, vials, systems, serum separators, blood collection
• Manufacturer (Section D): Becton Dickinson & CO (Franklin Lakes); 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): Becton Dickinson & CO (Franklin Lakes); 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: anand singh ; 1 becton drive; franklin lakes, NJ 07417 ; +1(201)847-5186
• MDR Report Key: 50734676
• Report Number: 2243072-2026-00616
• Device Sequence Number: 16095770
• Product Code: JKA
• UDI-Device Identifier: 30382903672814
• UDI-Public: (01)30382903672814(17)271031(10)24L1411
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K252506
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/18/2026

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: 367281
• Device Lot Number: 24L1411
• 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: 08/14/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/09/2024
• 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