MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 20CM (8") SET DE EXTENSIÓN DE DOS VÍAS CON 2 MICROCLAVE¿ CLEAR, LUER GIRATORIO; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number LAT-MC3312

Device Problem Material Rupture (1546)

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

Event Date 08/30/2023

Event Type  malfunction  

Manufacturer Narrative

The actual device is not available for evaluation.Two photos were shared by customer for evaluation.In the first photo a sealed package where the lot and item information are shown.The second photo, an unknown red fluid spilled around the gloves of the person through a cut on the tube.No additional damage were observed.Complaint of hole/cut/torn can be confirmed based on the photo provided by customer.The probable cause was due to overpressure the device during use.Lot history review was performed and no non conformities were found that would have led the reported complaint.

Event Description

The event involved a 20cm (8") set de extensión de dos vías con 2 microclave¿ clear, in which the customer reported that in the facility's diagnostic imaging service department, the device ruptured, preventing the flow of fluid.Because of the leakage of the patient's body fluids, the set was discarded due to the high risk of contamination.The event occurred during patient use, and no one was reported harmed as a result of this event but the procedure had to be performed again with a new device.

• Brand Name: 20CM (8") SET DE EXTENSIÓN DE DOS VÍAS CON 2 MICROCLAVE¿ CLEAR, LUER GIRATORIO
• 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. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17865609
• MDR Text Key: 325390369
• Report Number: 9617594-2023-00792
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00887709120440
• UDI-Public: (01)00887709120440(17)270801(10)7773967
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K100576
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 09/07/2023

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: LAT-MC3312
• Device Lot Number: 7773967
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2023
• Initial Date FDA Received: 10/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2022
• 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