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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B BRAUN MEDICAL INC. PERIFIX FX SPRINGWOUND EPIDURAL CATHETER ANESTHESIA CONDUCTION KIT

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B BRAUN MEDICAL INC. PERIFIX FX SPRINGWOUND EPIDURAL CATHETER ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number CE17TFC
Device Problems Insufficient Flow or Under Infusion (2182); Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/24/2021
Event Type  malfunction  
Event Description
The epidural catheter component of a combined spinal epidural had difficulty infusing during the patient's c section. After testing outside of the patient, it was noted that an infusion port was not working or was clogged. The patient received adequate anesthesia through the spinal epidural. Fda safety report id# (b)(6).
 
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Brand NamePERIFIX FX SPRINGWOUND EPIDURAL CATHETER
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
B BRAUN MEDICAL INC.
bethlehem PA 18018
MDR Report Key11998936
MDR Text Key256456952
Report NumberMW5101878
Device Sequence Number1
Product Code CAZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 06/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/01/2021
Device Model NumberCE17TFC
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/25/2021
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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