MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC./ICU MEDICAL, INC. HYPODERMIC NEEDLE PRO; NEEDLE, HYPODERMIC, SINGLE LUMEN

Lot Number	6100327
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Device malfunction - needle detached in pt's arm when administering im injection with smiths medical hypodermic needle pro 22g x 1 1/2 inch needle, the needle disconnected from the needle protection device.(at the grey hub, not luerlock connection) and stayed in pt's arm.

• Brand Name: HYPODERMIC NEEDLE PRO
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC./ICU MEDICAL, INC.
• MDR Report Key: 24549410
• Report Number: MW5184946
• Device Sequence Number: 9331058
• Product Code: FMI
• UDI-Device Identifier: 20351688046809
• UDI-Public: 20351688046809
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/04/2026

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: Health Professional
• Device Lot Number: 6100327
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/09/2026
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LITHIUM ER 900 MG/D; OLANZAPINE 10MG/D; SERTRALINE 200MG/D; TRIMETHOBENZAMIDE 200MG/M
• Outcome Attributed to Adverse Event: Other
• Patient Age: 26 YR
• Patient Sex: Male
• Patient Weight: 85 KG