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

Model Number	305196
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
No one was injured/hurt/affected.I opened an unopened hypodermic needle, and it has white gunk on it.The white stuff is normally securing the base of the needle but this one has like melted or something - splattered.Unsafe for use on a patient.I am reporting it because maybe there is a bad batch.18g x 1 1/2" tw 1.2mmx40mm.Ref 305196.Esp 4/30/2030.Lot 5092808.(b)(4).

• 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: 22850871
• Report Number: 22850871
• Device Sequence Number: 14543532
• Product Code: FMI
• UDI-Device Identifier: 00382903051960
• UDI-Public: (01)00382903051960
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 08/12/2025
• Report Date (Section F): 08/12/2025

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: Health Professional
• Device Model Number: 305196
• Device Catalogue Number: 305196
• Device Lot Number: 5092808
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/20/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/20/2025
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/12/2025