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

Catalog Number	011-A1000
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available and the investigation has not been complete.
Event or Problem Description
The complaint involved a nanoclave¿ connector.It was reported that a leak was found at the valve located between the the infusion line and the child's catheter which resulted in poor sedation.The child was uncomfortable and in pain, with an increased risk of extubating.The valve was changed two times.The problem persisted.The valve was removed from the infusion line.There was patient involvement, unknown adverse event/human harm.
Additional Manufacturer Narrative
The complaint could not be confirmed by the investigation.No product samples, pictures, or videos were received for investigation.Without the return of the used sample, a comprehensive failure investigation cannot be performed, and a cause cannot be determined.The device history review (dhr) was reviewed, and no nonconformities were found that would have led to the reported complaint.
Additional Manufacturer Narrative
Updated information: d9.Device received on 7/23/2025.Received one (1) used.List # 011-a1000, nanoclave¿ connector for inspection.As received, no damage or anomalies were observed.No mating device was returned.The set was leak tested per product specifications.No leakage was confirmed.The reported complaint cannot be replicated or confirmed.

• Brand Name: NANOCLAVE® CONNECTOR
• 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: 22194008
• Report Number: 9617594-2025-01221
• Device Sequence Number: 15780577
• Product Code: FPA
• UDI-Device Identifier: 00840619060909
• UDI-Public: (01)00840619060909(17)280201(10)13550697
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K970855
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/26/2025

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-A1000
• Device Lot Number: 13550697
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2025
• Supplement Date Received by Manufacturer: 06/23/2025; 09/02/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 07/21/2025; 09/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2023
• 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: CATHETER, MFR UNK; INFUSION LINE, MFR UNK; UNSPECIFIED SEDATIVE, MFR UNK
• Patient Sex: Unknown