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U.S. Department of Health and Human Services

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

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B. BRAUN MEDICAL INC. PERIFIX ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number 332079
Device Problems Material Too Rigid or Stiff (1544); Physical Resistance (2578)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/14/2017
Event Type  malfunction  
Event Description
During the placement of an epidural catheter the physician reported the catheter met resistance as it was being threaded through the needle. The physician removed the catheter and upon inspection he stated the end of the epidural catheter had a hard "bur". Manufacturer response for epidural catheter, perifix fx continuous epidural anesthesia tray (per site reporter): reporter not aware of response.
 
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Brand NamePERIFIX
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
901 marcon blvd.
allentown PA 18109
MDR Report Key6379911
MDR Text Key69128765
Report Number6379911
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 User Facility
Reporter Occupation
Type of Report Initial
Report Date 02/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2017
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2018
Device Model Number332079
Device Catalogue Number332079
Device Lot Number0061525163
Other Device ID NumberCE17TKFC
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/16/2017
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer02/16/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/06/2017 Patient Sequence Number: 1
Treatment
NO OTHER THERAPIES
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