MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 9" EXT SET W/0.2 MICRON FILTER, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number SC9045

Device Problem Break (1069)

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

Event Date 09/19/2023

Event Type  malfunction  

Event Description

The incident involved a 9" ext set w/0.2 micron filter, clamp, rotating luer.The customer reported that they had a tube/set that broke while using with a patient.The set-up included a 250ml bag of normal saline spiked with a meter tubing, which was then attached to filter.The medication involved was remicade.It was further reported that tubing set-up was replaced and treatment was resumed.Treatment had just started when the issue was noted.There was patient involvement and no human harm reported.

Manufacturer Narrative

The device has been requested to be returned for evaluation; however, it has not yet been received.E1: telephone extension (b)(6).

Manufacturer Narrative

No product samples, videos, or photographs were provided for investigation.The dhr was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.A probable cause cannot be identified based on the information that has been provided.The device history review for lot 13716157 was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.

• Brand Name: 9" EXT SET W/0.2 MICRON FILTER, CLAMP, ROTATING LUER
• 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: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18065008
• MDR Text Key: 327277793
• Report Number: 9617594-2023-00930
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709040625
• UDI-Public: (01)00887709040625(17)280701(10)13716157
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SC9045
• Device Lot Number: 13716157
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2023
• 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
• Treatment: NORMAL SALINE, MFR UNK; REMICADE, MFR UNK