MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 6" (15 CM) APPX 0.19 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, LUER LOCK; STOPCOCK, I.V. SET

Catalog Number K7073-001

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/04/2019

Event Type  malfunction  

Manufacturer Narrative

Multiple attempts have been made to retrieve the device; however, the location of the device is unknown.A device history review was not conducted because the lot number was not provided.Lack of the lot number provides manufacturing/expiry information to the manufacturer for further evaluation.

Event Description

It was reported that the sterile vacuum valve was cracked and soiled/contaminated on the inside.There was no patient harm reported.No additional information is available.

• Brand Name: 6" (15 CM) APPX 0.19 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, LUER LOCK
• 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; colonia rancho santa clara, ma; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: christopher zanoni ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 9274893
• MDR Text Key: 196652830
• Report Number: 9617594-2019-00377
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: K7073-001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2019
• 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