MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V JELCO HYPODERMIC NEEDLE-PRO NEEDLES; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	UNKNOWN
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was stated that the nurse prepared the suspension according to the instructions, drew it into a syringe, and began to inject the patient.During the injection, the needle detached/snapped from its base and the solution splashed everywhere, including on the nurse's face, but not in their eyes.According to the doctor's assessment, the patient was given an extra dose and the nurse got away with a scare.The incident took place in a hospital.There was patient involvement.

• Brand Name: JELCO HYPODERMIC NEEDLE-PRO NEEDLES
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V; carretera miguel aleman; km 21.7; monterrey 22425 ; MX 22425
• Manufacturer Contact: reed covert ; 10 bowman drive,; keene, NH 03431 ; +1(224)706-2300
• MDR Report Key: 24429206
• Report Number: 1217052-2026-00011
• Device Sequence Number: 10392949
• Product Code: FMI
• 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
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2026

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: UNKNOWN
• Device Lot Number: UNKNOWN
• 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: 02/02/2026
• Supplement Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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