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

Catalog Number	B3300
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Event or Problem Description
A microclave® neutral connector reportedly filled with blood and then leaked blood into the valguard and onto the linen.30 minutes after placing this device onto the patient's line, it was found to be faulty.There was no patient harm.
Additional Manufacturer Narrative
Investigation summary a photo where a bunch of claves are inside a plastic bag.However, no physical damage or anomalies were noted.One (1) used.List #b3300, clave¿ neutral connector was returned for evaluation.As received, a blood residual inside the clave was noted.The clave was tested as procedure and no internal/external leaks were noted.The clave was dissembled and no damage or anomalies were noted.A device history review was performed and no relevant discrepancies, anomalies or nonconformances were identified that might be related with the condition reported by customer.Complaint of leaks can be confirmed, based on the blood residual inside the clave.However, the probable cause is unknown.

• Brand Name: MICROCLAVE® NEUTRAL 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: 23383447
• Report Number: 9617594-2025-02041
• Device Sequence Number: 15614486
• Product Code: FPA
• UDI-Device Identifier: 00840619045593
• UDI-Public: (01)00840619045593(17)300401(10)14380092
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2025

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: B3300
• Device Lot Number: 14380092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2025
• Supplement Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2025
• 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: UNSPECIFIED PRIMARY IV LINE, MFR UNK.
• Patient Sex: Unknown