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

Catalog Number 12568

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2023

Event Type  malfunction  

Event Description

The event occurred on an unspecified date and involved a microclave® neutral connector where the customer reported inconsistent flow when using the microclave connector during patient use.There were no obvious defects on the device upon removal from the package.There was patient involvement, however, no patient harm was reported as a consequence of this event.

Manufacturer Narrative

E1 - telephone number - ext - (b)(6).The device is not available for investigation as the customer has discarded it.Without the return of the device, a probable cause is unable to be determined.

• Brand Name: CLAVE¿ NEUTRAL CONNECTOR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa.
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18477499
• MDR Text Key: 332998829
• Report Number: 9617594-2024-00019
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00887709042377
• UDI-Public: (01)00887709042377(17)270401(10)5916918
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K970855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/09/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 12568
• Device Lot Number: 5916918
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2023
• Initial Date FDA Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1