MAUDE Adverse Event Report: ICU MEDICAL, INC. CENTRAL VENOUS CATHETER KIT, HEPARIN COATED; CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number 414010423

Device Problem Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

We have had numerous problems where the wire will not thread through the needle in the past few months.We returned our stock to the mfr.Fda safety report id# (b)(4).

• Brand Name: CENTRAL VENOUS CATHETER KIT, HEPARIN COATED
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): ICU MEDICAL, INC. ; lake forest IL
• MDR Report Key: 9417819
• MDR Text Key: 169512696
• Report Number: MW5091462
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/02/2019
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 414010423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2019
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1