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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. ESPOCAN® SPINAL EPIDURAL ANESTHESIA KIT

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B. BRAUN MEDICAL INC. ESPOCAN® SPINAL EPIDURAL ANESTHESIA KIT Back to Search Results
Model Number ES1827KDS
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Information (3190)
Event Date 12/14/2017
Event Type  malfunction  
Event Description
The saline in the epidural kit which should be pf and for epidural use is labeled "for iv use only" with no mention of being pf. B. Braun's espocan combined spinal and epidural anesthesia tray has saline in the kit which should be pf (for epidural administration) but is listed as non pf and for iv use only. This could be detrimental to many patients if given epidural route.
 
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Brand NameESPOCAN®
Type of DeviceSPINAL EPIDURAL ANESTHESIA KIT
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
901 marcon blvd
allentown PA 18109
MDR Report Key7147315
MDR Text Key95806934
Report Number7147315
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
Type of Report Initial
Report Date 12/18/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/27/2017
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberES1827KDS
Device Catalogue Number333194
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/18/2017
Event Location Hospital
Date Report to Manufacturer12/18/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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