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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL, INC BRAUN PERIFIX FX EPIDURAL ANESTHESIA TRAY ANESTHESIA CONDUCTION KIT

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B. BRAUN MEDICAL, INC BRAUN PERIFIX FX EPIDURAL ANESTHESIA TRAY ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number REF 552020
Device Problem Mechanics Altered (2984)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 02/19/2019
Event Type  malfunction  
Event Description
Patient started complaining of feeling contractions following an epidural placement previously. Patient also stated that it was wet under her arm. After assessing the epidural it was discovered that the ¿clip¿ used to connect to the epidural tubing was undone. Epidural medicine stopped, doctor of anesthesiology notified. Doctor came to replace epidural. This is a new issue in last 2-3 months but becoming more frequent.
 
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Brand NameBRAUN PERIFIX FX EPIDURAL ANESTHESIA TRAY
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
B. BRAUN MEDICAL, INC
MDR Report Key8381685
MDR Text Key137559771
Report NumberMW5084513
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 02/27/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2020
Device Model NumberREF 552020
Device Catalogue NumberPRODUCT CODE: CESK
Device Lot Number0061639183
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?
Type of Device Usage

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