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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B BRAUN MEDICAL INC. PERIFIX CONTINUOUS EPIDURAL TRAY; ANESTHESIA CONDUCTION KIT
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B BRAUN MEDICAL INC. PERIFIX CONTINUOUS EPIDURAL TRAY; ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number CE18TK
Device Problems Break (1069); Detachment Of Device Component (1104); Physical Resistance (2578)
Patient Problem Foreign Body In Patient (2687)
Event Date 09/08/2014
Event Type  malfunction  
Event Description
An 18-gauge tuohy needle was advanced slowly at the same interspace using a midline approach until a loss of resistance was achieved.A 20-gauge catheter was advanced through the tuohy needle with some resistance and was therefore withdrawn to reposition the needle.When the catheter was pulled out the distal 7.5 cm was missing.The needle was reinserted until loss of resistance and the catheter was advanced without pain or parasthesias to a depth of four centimeters into the epidural space.Following delivery, the patient underwent ct of her spine which failed to locate the catheter segment.The 18 mm material, consistent with an epidural catheter, was found in the l3-4 left epidural space on several cuts.
 
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Brand Name
PERIFIX CONTINUOUS EPIDURAL TRAY
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
B BRAUN MEDICAL INC.
901 marcon boulevard
allentown PA 18109
MDR Report Key6166033
MDR Text Key62115567
Report Number6166033
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 11/15/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2016
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberCE18TK
Device Catalogue Number332220
Other Device ID NumberPRODUCT CODE: CE18TK
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/15/2016
Event Location Hospital
Date Report to Manufacturer11/15/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO OTHER THERAPIES
Patient Age27 YR
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