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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B BRAUN MEDICAL, INC. B BRAUN; PERIFIX FX CONTINUOUS EPIDURAL TRAY
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B BRAUN MEDICAL, INC. B BRAUN; PERIFIX FX CONTINUOUS EPIDURAL TRAY Back to Search Results
Model Number 332097
Device Problems Material Fragmentation (1261); Material Frayed (1262); Detachment of Device or Device Component (2907)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Foreign Body In Patient (2687)
Event Date 01/07/2015
Event Type  malfunction  
Event Description
After delivery of infant when rn removed epidural catheter, the tip was not intact on the catheter and the end was frayed.The epidural catheter was removed with no resistance or tugging by the rn.Pt also denies any resistance.Dr (b)(6), anesthesiologist, was notified by rn to come to evaluate pt.No palpable mass was noted by him.He explained to the pt there would be imaging studies done the next day to further evaluate.Dr (b)(6) notified the attending ob physician, (b)(6).Pt denied any numbness or tingling anywhere.
 
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Brand Name
B BRAUN
Type of Device
PERIFIX FX CONTINUOUS EPIDURAL TRAY
Manufacturer (Section D)
B BRAUN MEDICAL, INC.
824 12th ave
MDR Report Key4495536
MDR Text Key22031166
Report Number4495536
Device Sequence Number1
Product Code CAZ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 02/02/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number332097
Device Catalogue NumberCE17TKSCS
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/02/2015
Distributor Facility Aware Date01/20/2015
Event Location Hospital
Date Report to Manufacturer02/02/2015
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age30 YR
Patient Weight67
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