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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BRAUN PERIFIX CONTINUOUS EPIDURAL ANESTHESIA TRAY EPIDURAL CATHETER

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BRAUN PERIFIX CONTINUOUS EPIDURAL ANESTHESIA TRAY EPIDURAL CATHETER Back to Search Results
Lot Number 0061573999
Device Problems Break (1069); Detachment Of Device Component (1104); Physical Resistance (2578)
Patient Problems Tingling (2171); Foreign Body In Patient (2687)
Event Date 10/30/2017
Event Type  No Answer Provided  
Event Description
Upon placing epidural catheter at l4/5 level, pt experienced paresthesia on left side. Anesthesiologist withdrew catheter to readjust and encountered very little resistance, however, as pt jumped slightly, the catheter sheared off. About 5 cm was retained in presumed epidural space. No c/o pain, paresthesia, etc.
 
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Brand NamePERIFIX CONTINUOUS EPIDURAL ANESTHESIA TRAY
Type of DeviceEPIDURAL CATHETER
Manufacturer (Section D)
BRAUN
flowood MS 39232
MDR Report Key6995793
MDR Text Key90941738
Report NumberMW5073084
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 10/31/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/02/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2018
Device Lot Number0061573999
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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