MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® (GREEN, GLOW RINGS), 2 0.2 MICRON; STOPCOCK, I.V. SET

Model Number B33199

Device Problems Particulates (1451); Microbial Contamination of Device (2303)

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

Event Date 02/01/2023

Event Type  malfunction  

Manufacturer Narrative

The device has been requested for evaluation.However, it has not yet been received.

Event Description

The event involved a 7" (18 cm) smallbore trifuse ext set w/3 microclave® 2 rings (green, glow), 2-0.2 micron filters, 3 clamps, rotating luer on an unknown date.It was reported that there was mold inside the filtration piece of the device.The event happened on two occasions.There was unknown patient involvement and unknown human harm or adverse event.This is the first of two events.

Manufacturer Narrative

The complaint of particulate on the b33199 could not be confirmed by investigation.No product samples, pictures, or videos were received for investigation.Without the return of the sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The device history review (dhr) could not be performed due to the unknown lot number.

• Brand Name: 7" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® (GREEN, GLOW RINGS), 2 0.2 MICRON
• 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: 16485894
• MDR Text Key: 311254966
• Report Number: 9617594-2023-00092
• Device Sequence Number: 1
• Product Code: FMG
• 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: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B33199
• Device Catalogue Number: B33199
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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