MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. NEUTRON®; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	011-NC100
Medical Device Problem Codes	Backflow (1064); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a neutron® where it was reported there was a loss of medicinal product from the smart connected to the jugular catheter (primicath).Once the device has been removed from the child: testing the smart without applying upstream pressure: no anomalies were observed.Testing the smart while applying upstream pressure: the product backflow and leak.The corrective action was to replace the smart device.No clinical consequences have been noted.The status of the product at the time of the event is while connected to the jugular catheter.There was patient involvement and no adverse event/human harm.
Additional Manufacturer Narrative
The device has been received for evaluation.Investigation is pending.D4: only di provided as lot number is unknown.
Additional Manufacturer Narrative
One used # 011-nc100, neutron connected to an use unknown, clave and a bd 10ml syringe were returned for evaluation.As received the syringe was disconnected and the neutron's seal was damaged.The returned set was tested and a leak from inside the neutron was found.Once neutron was dissembled a torn/seal damage was observed.Complaint of leaks can confirmed.Even the id of the returned mating was found within specification, the probable cause is typical due to incompatible mating device during use, direction for use (dfu) states: neutron is compatible with iso male luers having an internal diameter greater than 0.061¿.A device history report (dhr) lot# review could not be conducted because no lot number(s) was/were identified.A dhr lot# review could not be conducted because no lot number(s) was/were identified.

• Brand Name: NEUTRON®
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. ; MX
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 21200957
• Report Number: 9617594-2025-00161
• Device Sequence Number: 7560232
• Product Code: FPA
• UDI-Device Identifier: 00840619054076
• UDI-Public: 00840619054076
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K100434
• 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,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2025

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: 011-NC100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2024
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PRIMICATH JUGULAR CATHETER.; UNSPECIFIED MEDICINAL PRODUCT, UNK MFR.
• Patient Sex: Unknown