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),; STOPCOCK, I.V. 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  

Manufacturer Narrative

The device is not available for investigation as the customer has discarded it.Complaint of particulate matter can be confirmed based on the photos received by customer.However because the physical sample was not returned for evaluation a probable cause cannot be determined.The device history review (dhr) for lot 13408928 was reviewed and no non conformities were found that would have led to the reported complaint.

Event Description

The incident involved a 15" (38 cm) appx 4.7 ml, bifuse add-on set w/2 bag spikes, 2 clamps (red, blue), plug adapter.The reporter stated that particulate matter was observed in the drip chamber after spiking with pump line.The event was noted during priming.There was no patient involvement and no patient harm.This is the third of three reports.

• Brand Name: 15" (38 CM) APPX 4.7 ML, BIFUSE ADD-ON SET W/2 BAG SPIKES, 2 CLAMPS (RED, BLUE),
• Type of Device: STOPCOCK, I.V. 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: 17163464
• MDR Text Key: 317504668
• Report Number: 9617594-2023-00254
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619024918
• UDI-Public: (01)00840619024918(17)271201(10)13408928
• 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

• Date FDA Received: 06/20/2023
• 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: 13408928
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2022
• 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