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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL PERIFIX FX 17G 3.5IN CONTINUOUS EPIDURAL ANESTHESIA

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B. BRAUN MEDICAL PERIFIX FX 17G 3.5IN CONTINUOUS EPIDURAL ANESTHESIA Back to Search Results
Model Number PRODUCT CODE: CE17TKFCS
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Pain (1994)
Event Date 08/11/2018
Event Type  malfunction  
Event Description
The clamp used to hold the catheter in place opened, and the tubing become detached from the clamp compromising the set up. The pt was in labor and receiving an epidural to help with labor pains when the problem with the equipment happened. Dates of use: (b)(6) 2018. Diagnosis or reason for use: labor pains.
 
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Brand NamePERIFIX FX 17G 3.5IN
Type of DeviceCONTINUOUS EPIDURAL ANESTHESIA
Manufacturer (Section D)
B. BRAUN MEDICAL
MDR Report Key7842439
MDR Text Key119328266
Report NumberMW5079547
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 08/29/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/31/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2019
Device Model NumberPRODUCT CODE: CE17TKFCS
Device Catalogue Number174873/332097
Device Lot Number0061623967
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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