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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PERIFLEX FX CONTINUOUS EPIDURAL ANESTHESIA ANESTHESIA CONDUCTION KIT

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B. BRAUN MEDICAL INC. PERIFLEX FX CONTINUOUS EPIDURAL ANESTHESIA ANESTHESIA CONDUCTION KIT Back to Search Results
Device Problems Break (1069); Material Frayed (1262)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/13/2019
Event Type  malfunction  
Event Description
The epidural catheter tubing was found to be broken/frayed at the yellow round connector piece between the pt and the epidural pump. It had to be removed and replaced with a new epidural. Fda safety report id# (b)(4).
 
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Brand NamePERIFLEX FX CONTINUOUS EPIDURAL ANESTHESIA
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
MDR Report Key8623817
MDR Text Key145627263
Report NumberMW5086732
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 05/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
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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