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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 TRAY ANESTHESIA CONDUCTION KIT

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B. BRAUN MEDICAL INC. PERIFIX FX CONTINUOUS EPIDURAL ANESTHESIA TRAY ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number CE17TKFCPS
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/04/2018
Event Type  malfunction  
Event Description
Epidural catheter placed without incident, however, the clamp style catheter connector was not patent when the connector was clamped onto the catheter. Several more trays from the same lot were subsequently opened and the same mfg issue was present. With each the connector can easily have fluid or air pushed through it but when it is clamped (with or without a catheter present) little to no fluid or air can be pushed.
 
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Brand NamePERIFIX FX CONTINUOUS EPIDURAL ANESTHESIA TRAY
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
breinigsville PA 18031
MDR Report Key7864548
MDR Text Key120101205
Report NumberMW5079698
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
0 Patients were 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
Device Expiration Date03/31/2019
Device Model NumberCE17TKFCPS
Device Catalogue Number332078
Device Lot Number0061622923
Was Device Available for Evaluation? No
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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