• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PERIFIX® ANESTHESIA CONDUCTION KIT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

B. BRAUN MEDICAL INC. PERIFIX® ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number CE17TKFC
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Incontinence (1928); Numbness (2415)
Event Date 10/15/2016
Event Type  Injury  
Manufacturer Narrative
This report has been identified as b. Braun medical inc. (b)(4). The actual device involved in the reported incident was not returned for evaluation. Without the lot number, a batch record review could not be performed. No specific conclusions can be drawn. It was indicated in the event summary that multiple drug products were administered during the procedure. The reported kit catalog number contains the following drugs: 5 ml lidocaine 1% test dose 1. 5 % lidocaine with epinephrine. No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or involved drugs. All available information has been forwarded to the drug manufacturer. There is no current information available to suggest that the b. Braun product caused or contributed to the reported event. If additional pertinent information that impacts the result of the investigation becomes available, a follow-up report will be filed.
 
Event Description
As reported by the user facility: reports the patient had a neurotoxicity after the procedure. The patient started labor with twins. An epidural was performed with the catheter. Patient was converted to a c-section. After the procedure, the patient had numbness and weakness bilaterally in lower extremities and bladder incontinence. Patient had inability to walk at all for approximately 1 week. The patient is currently walking with a cane. All tests including mri and emg were negative for a biologic cause. The facility protocol is to skin prep with chlora-prep prior to all epidurals and spinals, and not use prep in tray. Drugs given to patient were lidocaine with epinephrine from tray, skin wheel with lidocaine, bupivacaine, morphine, and fentanyl. Per follow-up correspondence with the reporting facility, the patient had no prior medical history, no renal diagnosis. It was determined that there were no issues with the insertion. The patient was sitting during prep, epidural inserted mid-line, l3-l4 for original plan of vaginal delivery. The patient was given 8 ml push of 0. 25% bupivacaine and 100 mcg fentanyl, infusion of premade bag of 0. 06% bupivacaine with fentanyl was set at 15 ml over 2 hours. Patient was converted to c-section due to the fetus not being in correct position for vaginal delivery. Patient was then given lidocaine 2% with epinephrine, 15 ml zofran, fentanyl, and 2 mg morphine-intravenous. At an unknown time the patient experienced calf pain. Bilateral dopplers were done, results negative. The patients inability to walk has resolved.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePERIFIX®
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
901 marcon blvd.
allentown PA 18109
Manufacturer Contact
bridseida melendez
901 marcon blvd
allentown, PA 18109
6102660500
MDR Report Key6118084
MDR Text Key60558700
Report Number2523676-2016-00803
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K813186
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 10/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCE17TKFC
Device Catalogue Number332079
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/28/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/21/2016 Patient Sequence Number: 1
-
-