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	Detachment of Device or Device Component (2907)
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: month and year are known, no device was received for investigation.Therefore, the reported complaint is unable to be confirmed.If the device is received, the investigation will be re-opened for further evaluations.
Event or Problem Description
It was reported that the complaint is about a detached needle.After the dose had been delivered, as the nurse went to remove the syringe/needle from the patient, the syringe was removed but the needle remained in the patient.There was then a needle stick injury to a member of staff when trying to remove the needle from the patient¿s injection site.There was patient involvement.

• 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, NH 03431 ; 2247062300
• MDR Report Key: 23921472
• Report Number: 1217052-2025-00116
• Device Sequence Number: 9152450
• Product Code: FMI
• UDI-Device Identifier: 00351688072545
• UDI-Public: (01)00351688072545(17)291016(10)6064770
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/30/2025

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: Other
• Device Catalogue Number: EL31915
• Device Lot Number: 6064770
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/19/2024
• 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