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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL, INC. CUSTOM SPINAL KIT EPIDURAL ANESTHESIA KIT

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B. BRAUN MEDICAL, INC. CUSTOM SPINAL KIT EPIDURAL ANESTHESIA KIT Back to Search Results
Lot Number 6318
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Pain (1994); Patient Problem/Medical Problem (2688)
Event Date 05/30/2018
Event Type  Injury  
Event Description
Young female at (b)(6) gestation was scheduled for mcdonald cerclage with bladder flap dissection procedure due to history of asymptomatic cervical dilation in prior pregnancies. Spinal placed by anesthesia; no complications noted in the procedure note. Per the operative report, the patient had continued pain despite the spinal block. Per anesthesia report, spinal kit bupivacaine did not work completely, resulting in an inadequate level of anesthesia. General anesthesia was required to complete the procedure. Following initiation of general anesthesia, the procedure was completed without further complication. Manufacturer response for custom spinal kit, b. Braun (per site reporter). B. Braun was notified of this issue as it has happened more than once since start of this year. There have been multiple discussions between b. Braun, anesthesia and the materials processing department of facility. Facility removed the lot # from stock, and has now worked with b. Braun to remove the medication from the kit completely in an effort to prevent this type of event. Facility has continued concern regarding temperature management prior to the kits arriving and has shared these concerns with b. Braun.
 
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Brand NameCUSTOM SPINAL KIT
Type of DeviceEPIDURAL ANESTHESIA KIT
Manufacturer (Section D)
B. BRAUN MEDICAL, INC.
901 marcon blvd
allentown PA 18109
MDR Report Key7666068
MDR Text Key113333074
Report Number7666068
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 06/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2018
Is this an Adverse Event Report? Yes
Device Operator
Device Lot Number6318
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/27/2018
Event Location Hospital
Date Report to Manufacturer07/06/2018
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

Patient Treatment Data
Date Received: 07/06/2018 Patient Sequence Number: 1
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