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	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Received a pair of photos from the customer showing the packaging of the affected sample.No conclusions could be made from the photos provided.Without the return of the sample a comprehensive review cannot be performed and a probable cause cannot be determined.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.Section e initial reporter (full) phone: (b)(6).
Event or Problem Description
The customer-reported event occurred on an unspecified date and involved a microclave® neutral connector.The clave adaptor of the device reportedly disconnected from the end of the port two days in a row.The clave adaptor was successfully connected to the end of the port both times and was running without issue initially.The second time, the nurse went to access the port and the clave popped out, no leaking observed at this time.This occurred while attached to the patient.During this second occurrence, the clave adapter popped off when the nurse was attaching the syringe.The involved patient was not harmed although it was unclear how much medication was received as the fluid was leaking out.The hospital for sick kids was consulted, and an alternate antibiotic was given.This emdr reflects the second of two occurences.

• 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: 24282700
• Report Number: 9617594-2026-00087
• Device Sequence Number: 8318555
• Product Code: FPA
• UDI-Device Identifier: 00840619045593
• UDI-Public: (01)00840619045593(17)300701(10)14503797
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/06/2026

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: B3300
• Device Lot Number: 14503797
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/28/2025
• 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: SYRINGE, MFR UNK; UNSPECIFIED FLUID/INFUSATE, MFR UNK
• Patient Sex: Unknown