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

Catalog Number	EL31915
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event is unknown; investigation including root cause analysis is in progress.A supplemental mdr will be filled as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that the piston became blocked and the needle dislodged, preventing the injection of the product and resulting in its loss.The incident occurred during administration.There was a patient involvement and no harm reported.
Additional Manufacturer Narrative
D3: mfg establishment name; icu medical healthcare manufacturing s.A.De c.V.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 NEEDLE-PRO W/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 CP666 03; MX CP66603
• Manufacturer Contact: reed covert ; 10 bowman drive; keene; keene, NH 03431 ; 2247062300
• MDR Report Key: 23403903
• Report Number: 1217052-2025-00107
• Device Sequence Number: 11993954
• Product Code: FMI
• UDI-Device Identifier: 00351688072545
• UDI-Public: (01)00351688072545(17)291004(10)6064765
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 03/31/2026

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: EL31915
• Device Lot Number: 6064765
• 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: 10/06/2025
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/30/2024
• 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