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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PERIFIX CATHETER CONNECTOR ANESTHESIA CONDUCTION KIT

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B. BRAUN MEDICAL INC. PERIFIX CATHETER CONNECTOR ANESTHESIA CONDUCTION KIT Back to Search Results
Device Problems Detachment of Device or Device Component (2907); Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/28/2018
Event Type  malfunction  
Event Description
Pt had an epidural placed at about 0520 in the morning. At about 1000, as the nurse adjusted the pt's position in bed, she noticed the epidural catheter hanging down off the side of the bed, unconnected from the pump tubing. Upon further investigation, she found the connector closed, but was able to open it with minimal effort. While discussing this incident with other nurses on the unit, they reported 2 other similar incidents where the connector was found open and the tubing no longer attached appropriately. In the incident regarding the pt in this report, the epidural catheter was removed and a whole new epidural was placed.
 
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Brand NamePERIFIX CATHETER CONNECTOR
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
allentown PA 18109
MDR Report Key7864363
MDR Text Key119944335
Report NumberMW5079686
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 09/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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: 09/10/2018 Patient Sequence Number: 1
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