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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PERIFIX® CONTINUOUS EPIDURAL TRAY PERIFIX FX EPIDURAL CATHETER

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B. BRAUN MEDICAL INC. PERIFIX® CONTINUOUS EPIDURAL TRAY PERIFIX FX EPIDURAL CATHETER Back to Search Results
Model Number CE17TKFC
Device Problems Material Fragmentation (1261); Unraveled Material (1664); Failure to Advance (2524)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 10/08/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The actual device involved in the reported incident was not returned for evaluation. However, the facility did return a photo of the involved catheter. Based on the photo, the catheter appeared to be fractured / sheared at the tip end, with the inner coil unwound and stretched out at the area of the break. However, no specific conclusions can be drawn from the photo. The reporting facility indicated that there was resistance when attempting to pass the catheter. While no specific conclusion can be drawn, incidents of this nature can occur when a catheter becomes lodged between rigid body structures and is stretched beyond its design capabilities; or if the catheter is withdrawn or partially withdrawn through the needle, thereby shearing the catheter. Per the instructions for use (ifu) for the reported product catalog number, "do not withdraw catheter through needle because of the possible danger of shearing or kinking. " review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or nonconformances of this nature. No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or catheter material number. There were no other reports of this nature against the reported lot number. If additional pertinent information becomes available, a follow-up report will be filed.
 
Event Description
As reported by the user facility: reports patient was receiving an epidural in labor & delivery. While attempting to pass the catheter, it would not advance. When the catheter was removed, the blue tip was missing and the catheter unraveled. The sheared catheter tip currently remains in the patient. It is unsure at this time if the patient will electively remove the catheter fragment.
 
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Brand NamePERIFIX® CONTINUOUS EPIDURAL TRAY
Type of DevicePERIFIX FX EPIDURAL CATHETER
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 Key6067346
MDR Text Key59075329
Report Number2523676-2016-00691
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 10/11/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/31/2016
Is this an Adverse Event Report? No
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? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/11/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/27/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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