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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. DESIGN OPTIONS®; EPIDURAL ANESTHESIA KIT
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B. BRAUN MEDICAL INC. DESIGN OPTIONS®; EPIDURAL ANESTHESIA KIT Back to Search Results
Catalog Number 552122
Medical Device Problem Code Difficult To Position (1467)
Health Effect - Clinical Code Cerebrospinal Fluid Leakage (1772)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).Multiple unsuccessful attempts were made to obtain a sample and lot number.Without the actual device and/or lot number, a thorough investigation could not be performed.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If a sample and/or any additional pertinent information becomes available, a follow up will be submitted.
 
Event or Problem Description
As reported by the user facility: event 3: lor needle causing dura puncture.Tuohy needle did not achieve loss of resistance and the needle advanced to far causing dura puncture.At least two patients had to have a blood patch.
 
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Brand Name
DESIGN OPTIONS®
Common Device Name
EPIDURAL ANESTHESIA KIT
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
901 marcon blvd.
allentown PA 18109
MDR Report Key6648915
Report Number2523676-2017-00097
Device Sequence Number892746
Product Code OGE
UDI-Device Identifier04046955056842
UDI-Public04046955056842
Combination Product (Y/N)N
Initial Reporter StateMD
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Health Professional
Type of Report Initial
Report Date (Section B) 05/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Catalogue Number552122
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/24/2017
Initial Report FDA Received Date06/16/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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