MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY N/A; SYRINGE, PISTON

Model Number	302832
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
While preparing a dose, the iv technician discovered a 30 ml syringe with debris embedded inside.No dose made with it.Moc [manager on call] contacted.Collected affected syringe and will save for collection/evaluation.Iv technicians will continue to monitor.Manufacturer letter of investigation and photo added to this report.Bd 30 ml syringe luer-lok tip - embout bd luer-lok, (b)(4), exp: 2030-05-31, lot: 5176260.Manufacturer response for 30 ml syringe luer-lok tip, 30 ml syringe luer-lok tip - embout bd luer-lok (per site reporter).

• Brand Name: N/A
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton dr; franklin lakes NJ 07417
• MDR Report Key: 24477525
• Report Number: 24477525
• Device Sequence Number: 21396050
• Product Code: FMF
• UDI-Device Identifier: 00382903028320
• UDI-Public: (01)00382903028320
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/24/2026
• Report Date (Section F): 02/24/2026

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
• Device Model Number: 302832
• Device Catalogue Number: 302832
• Device Lot Number: 5176260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/02/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/02/2026
• 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: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/24/2026