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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BRAUN / B. BRAUN MELSUNGEN AG PERIFLEX EPIDURAL ANESTHESIA TRAY ANESTHESIA CONDUCTION KIT

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BRAUN / B. BRAUN MELSUNGEN AG PERIFLEX EPIDURAL ANESTHESIA TRAY ANESTHESIA CONDUCTION KIT Back to Search Results
Lot Number 0061747995
Device Problem Material Separation (1562)
Patient Problem Foreign Body In Patient (2687)
Event Date 01/07/2021
Event Type  malfunction  
Event Description
Upon removal of periflex epidural catheter, a portion of catheter tip was retained. Retained portion left in place. Fda safety report id # (b)(4).
 
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Brand NamePERIFLEX EPIDURAL ANESTHESIA TRAY
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
BRAUN / B. BRAUN MELSUNGEN AG
MDR Report Key11169999
MDR Text Key227081362
Report NumberMW5098813
Device Sequence Number1
Product Code CAZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 01/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number0061747995
Was Device Available for Evaluation? No
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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