MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. NEUTRON¿ CONNECTOR, BULK NON-STERILE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	NC100-NS
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a neutron, and it was reported that the total parenteral nutrition and lipids leaked into the empty space between the outside of the neutron and the inner chamber.There was patient involvement, and patient harm is unknown.
Additional Manufacturer Narrative
One (1) used device was returned for evaluation.The neutron was tested as per procedure, and no internal leaks was observed.Once the sample was dissembled a tear at the top and the side in the seal was observed.Even during testing a leak was not able to be replicated, based on the damage observed on the seal, the complaint of leakage can be confirmed.The probable cause is typical due to incompatible mating device during use.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.Dfu states: the clave connector is compatible with luers with an internal diameter (id) between 0.062" and 0.110".

• Brand Name: NEUTRON¿ CONNECTOR, BULK NON-STERILE
• 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. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 25516874
• Report Number: 9617594-2026-00606
• Device Sequence Number: 10013487
• Product Code: FPA
• UDI-Device Identifier: 00840619065485
• UDI-Public: (01)00840619065485(10)300901(17)14595360
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/16/2026

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: NC100-NS
• Device Lot Number: 14595360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2025
• 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: PICC LINE, UNK MFR.; SMOF, UNK MFR.; TOTAL PARENTERAL NUTRITION, UNK MFR.
• Patient Sex: Unknown