MAUDE Adverse Event Report: ICU Medical Healthcare Manufacturing S.A. de C.V. HYPO NEEDLE-PRO 19G X 1 1/2" 800/CA; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	EL1915
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a detached needle.In one case a nurse noticed that the needle detached before administration.The nurse had no contact with the solution; the patient received the full dose.In a second case a nurse experienced the needle detaching with approximately 0.5 ml remaining in the syringe, as a result the nurse got in direct contact with the solution; the patient received a partial dose.The needle was removed.There was no reported patient harm or adverse event.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.

• Brand Name: HYPO NEEDLE-PRO 19G X 1 1/2" 800/CA
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): ICU Medical Healthcare Manufacturing S.A. de C.V.; carretera miguel alemán km21.7; parque industrial monterrey; apodaca nuevo leon NA 66603 ; MX 66603
• Manufacturer Contact: reed covert ; 10 bowman drive; keene, NH 03431 ; +1(224)706-2300
• MDR Report Key: 24691712
• Report Number: 1217052-2026-00017
• Device Sequence Number: 9726549
• Product Code: FMI
• UDI-Device Identifier: 20351688075670
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K923127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2026

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 Catalogue Number: EL1915
• Device Lot Number: 4289384
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2026
• Supplement Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/12/2022
• 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