• 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 FX CONTINUOUS EPIDURAL ANESTH. TRAY WINGED & SPRINGWOUND EPIDURAL CATHETER

  • 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 FX CONTINUOUS EPIDURAL ANESTH. TRAY WINGED & SPRINGWOUND EPIDURAL CATHETER Back to Search Results
Model Number CE17TKFC
Device Problems Component Missing (2306); Failure to Advance (2524)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 10/08/2016
Event Type  Injury  
Event Description
During epidural placement, first catheter would not advance through the tuohy needle. It was pulled out and noticed that the end unraveled and the blue tip was not present. Ct findings show a tiny 4-5 mm in length linear density within the spinal canal, adjacent to the left side of the call sac, suspicious for foreign body. No pt harm incurred.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePERIFIX FX CONTINUOUS EPIDURAL ANESTH. TRAY
Type of DeviceWINGED & SPRINGWOUND EPIDURAL CATHETER
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
bethlehem PA 18018 3524
MDR Report Key6078536
MDR Text Key59295588
Report NumberMW5065809
Device Sequence Number1
Product Code CAZ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 10/10/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/02/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2018
Device Model NumberCE17TKFC
Device Catalogue Number332079
Device Lot Number0061510725
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
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

-
-