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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PERIFIX

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PERIFIX Back to Search Results
Model Number ES18271K
Device Problems Difficult to Remove (1528); Device Or Device Fragments Location Unknown (2590)
Patient Problem Foreign Body In Patient (2687)
Event Date 01/11/2016
Event Type  Injury  
Event Description
Anesthesia had difficulty removing catheter. Once it was removed, the tip could not be identified. It is believed that approx 1cm of the catheter was retained in the pt's back.
 
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Brand NamePERIFIX
Type of DevicePERIFIX
MDR Report Key5384868
MDR Text Key36883527
Report NumberMW5059566
Device Sequence Number1
Product Code CAZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Attorney
Type of Report Initial
Report Date 01/18/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/18/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2016
Device Model NumberES18271K
Device Catalogue Number333192
Device Lot Number0061429079
Other Device ID Number08021-3331-92
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 01/18/2016 Patient Sequence Number: 1
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