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

Catalog Number	EL31915
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while drawing up, the needle shaft disconnected from needle hub due to fault with needle, causing reconstitution to spill so unable to draw up required dose.It was reported that there was patient involvement but no reported patient harm.
Additional Manufacturer Narrative
Device evaluation: no product returned for device analysis; a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product was returned; therefore, no visual and functional tests were performed, the reported complaint could not be confirmed, and the root cause could not be determined.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• Brand Name: JELCO HYPODERMIC N-PRO SYRINGE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V; carretera miguel aleman km; parque industrial monterrey; apodaca nl ; MX
• Manufacturer Contact: reed covert ; 10 bowman dr; keene, NH 03431 ; 2247062300
• MDR Report Key: 23768678
• Report Number: 1217052-2025-00114
• Device Sequence Number: 13197260
• Product Code: FMI
• UDI-Device Identifier: 00351688072545
• UDI-Public: (01)00351688072545
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/10/2025

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 Catalogue Number: EL31915
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 12/10/2025
• 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