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

Catalog Number	011-C3300
Medical Device Problem Codes	Blocked Connection (2888); No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device has been received but evaluation has not been completed.
Event or Problem Description
Event involves a clave¿ neutral connector intravenous catheter + y-site extension set +infusion set where the reporter stated that an obstruction- blood, was stuck in the clave during the infusion.They sated that the drugs involved were anesthetics, glucose, or antibiotics.There was no bleedback reported.There was no patient harm/adverse and no delay in critical therapy event reported as a result of this event.
Additional Manufacturer Narrative
Investigation summary received one (1) used 011-c3300 clave neutral connector for inspection.Blood residuals were observed outside of the fluid path between the male luer and the threads.The male luer of the microclave was leak tested and measured dimensionally and was found to meet product performance and dimensional specifications.The reported complaint can be confirmed.The probable cause is unknown.No mating devices were returned for inspection.A device history lot review could not be conducted because no lot number(s) was/were identified.

• Brand Name: CLAVE¿ NEUTRAL CONNECTOR
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR ADMINISTRATION SET.
• 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: 22537194
• Report Number: 9617594-2025-01485
• Device Sequence Number: 7488186
• Product Code: FPA
• UDI-Device Identifier: 00840619001421
• UDI-Public: 00840619001421
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2025

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-C3300
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Supplement Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 08/27/2025
• 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: ANESTHETICS, UNKNOW MFR.; ANTIBIOTICS, UNKNOWN MFR.; GLUCOSE, UNKNOWN MFR.
• Patient Sex: Unknown