MAUDE Adverse Event Report: MEDSOURCE INTERNATIONAL, LLC CLEARSAFE COMFORT SAFETY IV CATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT TERM

Model Number MS-84220

Device Problem Detachment Of Device Component (1104)

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

Event Date 04/10/2016

Event Type  malfunction  

Manufacturer Narrative

The catheter sample involved was not returned for evaluation. Multiple (4) attempts were made to gather additional information from the hospital and emergency service to no avail. Without a sample, a root cause for this incident cannot be determined.

Event Description

(b)(6) fire was notified by (b)(6) hospital of an inserted iv catheter that resulted in an unplanned surgical procedure on one of their patients. As the iv was discontinued by the er, 1" of the iv catheter remained inside the patient's arm. The remaining 1/4" remained connected to the catheter hub. It was reported that the iv placement was in the patient's right antecubital fossa (inside bend of the right elbow). An unspecified amount of dextrose 10% was infused through the iv by (b)(6) fire. The type of surgical procedure was not provided to medsource. It was also reported that no injuries occurred other than the catheter remaining in the patient's arm.

• Brand Name: CLEARSAFE COMFORT SAFETY IV CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT TERM
• Manufacturer (Section D): MEDSOURCE INTERNATIONAL, LLC; 4201 norex drive; chaska MN 55318
• Manufacturer (Section G): MEDSOURCE INTERNATIONAL, LLC; 4201 norex drive; chaska MN 55318
• Manufacturer Contact: laura riggen ; 4201 norex drive; chaska, MN 55318
• MDR Report Key: 5664830
• Report Number: 3003674698-2016-90001
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150611
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 05/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Emergency Medical Technician
• Device Expiration Date: 09/01/2020
• Device Model Number: MS-84220
• Device Lot Number: 50731/0566
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/11/2016
• 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 Outcome(s): Required Intervention