MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 15" (38 CM) APPX 4.7 ML, BIFUSE ADD-ON SET W/2 BAG SPIKES, 2 CLAMPS (RED, BLUE),; INTRAVENOUS ADMINISTRATION TUBING EXTENSION SET

Catalog Number CH3139

Device Problem Particulates (1451)

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

Event Date 05/24/2023

Event Type  malfunction  

Event Description

It was reported that a 15" (38 cm) appx 4.7 ml, bifuse add-on set w/2 bag spikes, 2 clamps (red, blue), plug adapter contained ¿particulate matter observed in drip chamber after spiking with pump line".The events were noted during priming.Unknown as to how long the sets were used.No medication was being used with the products.Someone became aware of the event when the floating particles in the solution were seen.Sample pictures of the one set where 2 photos were taken to that spike, floating white particulate inside the chamber with fluids were highlighted were available.No sample photo was provided for the other spike, but the reporter tried to find plastic in the chamber but was unable to locate.There was no patient involvement, no patient harm, there was no delay in therapy, and no one was harmed because of the reported event.

Manufacturer Narrative

Complaints of particulate matter can be confirmed based on the photos received by the customer.However, due to the physical sample not returned for evaluation a probable cause cannot be possible to determine.The device history review (dhr) for lot 5675428 was performed and no non-conformities were found that would have led to the reported complaint.

• Brand Name: 15" (38 CM) APPX 4.7 ML, BIFUSE ADD-ON SET W/2 BAG SPIKES, 2 CLAMPS (RED, BLUE),
• Type of Device: INTRAVENOUS ADMINISTRATION TUBING EXTENSION 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17195973
• MDR Text Key: 318210167
• Report Number: 9617594-2023-00269
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619024918
• UDI-Public: (01)00840619024918(17)261101(10)5675428
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K964435
• 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: 05/26/2023

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: CH3139
• Device Lot Number: 5675428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2023
• Initial Date FDA Received: 06/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2021
• 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