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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL, INC. PERIFIX FX CONTINUOUS EPIDURAL ANESTHESIA CONNECTOR EPIDURAL CATHETER CONNECTOR

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B. BRAUN MEDICAL, INC. PERIFIX FX CONTINUOUS EPIDURAL ANESTHESIA CONNECTOR EPIDURAL CATHETER CONNECTOR Back to Search Results
Model Number CE17TKFCS
Device Problems Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/17/2018
Event Type  malfunction  
Event Description
Per a report from the staff, they identified that the epidural catheter was not clamped into the epidural tubing which caused the epidural fluid to leak onto the pt's bed. The pt was in labor at this time and in the process of pushing. Is the product compounded: no; is the product over-the-counter: no.
 
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Brand NamePERIFIX FX CONTINUOUS EPIDURAL ANESTHESIA CONNECTOR
Type of DeviceEPIDURAL CATHETER CONNECTOR
Manufacturer (Section D)
B. BRAUN MEDICAL, INC.
allentown PA
MDR Report Key7797273
MDR Text Key117769387
Report NumberMW5079230
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 08/16/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/30/2019
Device Model NumberCE17TKFCS
Device Catalogue Number332097
Device Lot Number0061598516, 0061618405
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

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