Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 PERIFIX FX SPRINGWOUND EPIDURAL CATHETER; EPIDURAL CATHETER 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 PERIFIX FX SPRINGWOUND EPIDURAL CATHETER; EPIDURAL CATHETER KIT Back to Search Results
Model Number CE17TKFCS
Device Problem Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/29/2018
Event Type  Injury  
Event Description
During removal of the intra-articular catheter following a right total knee arthroplasty, when approximately 2/3 of the way through the removal, the catheter became more flexible and 2-3 distinct wire like strands appeared.The plastic coating sheath was not apparent.No blue catheter tip was noted at the end of the catheter.Surgeon was notified, x-ray obtained which showed a linear radiopacity projected along the volar aspect of the femoral component of the prosthesis on the lateral view raising the possibility of a retained catheter fragment or wire.Patient returned to surgery the following day for removal of the catheter fragment.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PERIFIX FX SPRINGWOUND EPIDURAL CATHETER
Type of Device
EPIDURAL CATHETER KIT
Manufacturer (Section D)
B BRAUN
bethlehem PA 18018
MDR Report Key7850854
MDR Text Key119570348
Report NumberMW5079616
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 Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 08/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2019
Device Model NumberCE17TKFCS
Device Catalogue Number332097
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age81 YR
-
-