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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PERIFIX AND CONTIPLEX CATHETER EPIDURAL CATHETER

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B. BRAUN MEDICAL INC. PERIFIX AND CONTIPLEX CATHETER EPIDURAL CATHETER Back to Search Results
Model Number 19 GAUGE PERIFIX FX CONTINUOUS
Device Problems Coiled (1098); Difficult to Remove (1528); Failure to Advance (2524); Physical Resistance (2578)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 05/27/2016
Event Type  malfunction  
Event Description
Crna attempted to insert epidural catheter unable to advance far enough in. Attempted to remove catheter, after 1 inch had been pulled out, resistance was met. Despite repositioning of patient, turning bevel of needle and removing the needle ,the catheter would not come out. After the needle was removed, tension was applied to the catheter and a coiled strand was removed. It did not appear as if the catheter was still completely intact. The catheter was measured against a new catheter and it is approx. 3/4 inch shorter. A (b)(6) year old gravida 2 female admitted with decreased fetal movement and found with no amniotic fluid (bbp 6 of 8). Labor was induced using cervidil and pitocin. A second epidural catheter was inserted 2 levels above without difficulty. After delivery, the second epidural catheter was removed without difficulty.
 
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Brand NamePERIFIX AND CONTIPLEX CATHETER
Type of DeviceEPIDURAL CATHETER
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
bethlehem PA 18018
MDR Report Key5705313
MDR Text Key46795150
Report NumberMW5062698
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 06/03/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/01/2018
Device Model Number19 GAUGE PERIFIX FX CONTINUOUS
Device Catalogue NumberCE17TKFCPS
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? 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: 06/03/2016 Patient Sequence Number: 1
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