MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY N/A; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	305127
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
25-gauge needle broke at hub while injecting patient during robotic surgery.The needle migrated to the patient's lung and was removed via robotic exploratory surgery.

• Brand Name: N/A
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton dr; franklin lakes NJ 07417
• MDR Report Key: 22060196
• Report Number: 22060196
• Device Sequence Number: 15572777
• Product Code: FMI
• UDI-Device Identifier: 00382903051274
• UDI-Public: (01)00382903051274
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/07/2025
• Report Date (Section F): 05/07/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 305127
• Device Catalogue Number: 305127
• Device Lot Number: 4247061
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/21/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/21/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Life Threatening
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 95 KG
• Date Report Sent to FDA: 05/07/2025