MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 6" (15 CM) APPX 0.26 ML, SMALLBORE EXT SET W/CLAMP, NANOCLAVE T-CONNECTOR, ROTA; STOPCOCK, I.V. SET

Model Number A1001

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/23/2020

Event Type  malfunction  

Manufacturer Narrative

No product samples, videos, or photographs were returned for investigation.A dhr lot review could not be conducted because no lot number(s) was/were identified.A probable cause cannot be identified based on the information that has been provided.

Event Description

The event involved a 6" (15 cm) appx 0.26 ml, smallbore ext set w/clamp, nanoclave¿ t-connector, rotating luer that the customer reported having difficulty disconnecting the t-connector on the red line.When the cat team separated the t-connector from the line, they noticed a part of the tubing retained in the red hub and a tegaderm was placed.There was patient involvement and no report of adverse event.

• Brand Name: 6" (15 CM) APPX 0.26 ML, SMALLBORE EXT SET W/CLAMP, NANOCLAVE T-CONNECTOR, ROTA
• 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: 11274006
• MDR Text Key: 258387183
• Report Number: 9617594-2021-00026
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/19/2021

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 Model Number: A1001
• Device Catalogue Number: A1001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2021
• Initial Date FDA Received: 02/03/2021
• 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