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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B BRAUN PERIFIX FX SPRINGWOUND EPIDURAL CATHETER EPIDURAL CATHETER KIT

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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.
 
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Brand NamePERIFIX FX SPRINGWOUND EPIDURAL CATHETER
Type of DeviceEPIDURAL 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
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
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 the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 09/05/2018 Patient Sequence Number: 1
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