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U.S. Department of Health and Human Services

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

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MEDSOURCE INTERNATIONAL, LLC CLEARSAFE COMFORT SAFETY IV CATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT TERM Back to Search Results
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.
 
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Brand NameCLEARSAFE COMFORT SAFETY IV CATHETER
Type of DeviceCATHETER, 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 Key5664830
MDR Text Key46368339
Report Number3003674698-2016-90001
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K150611
Number of Events Reported1
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 Received05/18/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Emergency Medical Technician
Device Expiration Date09/01/2020
Device Model NumberMS-84220
Device Lot Number50731/0566
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 Received04/11/2016
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 Treatment Data
Date Received: 05/18/2016 Patient Sequence Number: 1
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