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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL, INC. EPIDURAL CATHETER

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B. BRAUN MEDICAL, INC. EPIDURAL CATHETER Back to Search Results
Device Problems Break (1069); Material Separation (1562); Physical Resistance/Sticking (4012)
Patient Problem Foreign Body In Patient (2687)
Event Date 08/18/2020
Event Type  Injury  
Event Description
Epidural catheter used during tka. Upon removal, resistance noted. Catheter broke with approx 4 retained. Pt ultimately had to return to operating room for removal of remaining catheter. Fda safety report id# (b)(4).
 
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Brand NameEPIDURAL CATHETER
Type of DeviceEPIDURAL CATHETER
Manufacturer (Section D)
B. BRAUN MEDICAL, INC.
MDR Report Key10477593
MDR Text Key205334433
Report NumberMW5096360
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 08/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? 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

Patient Treatment Data
Date Received: 08/31/2020 Patient Sequence Number: 1
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