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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PERIFIX CATHETER CONNECTOR BRAUN MELSUNGEN AG (BBMAG) ANESTHESIA CONDUCTION KIT

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B. BRAUN MEDICAL INC. PERIFIX CATHETER CONNECTOR BRAUN MELSUNGEN AG (BBMAG) ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number 8451290
Device Problem Disconnection (1171)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/13/2018
Event Type  Injury  
Event Description
Rn assessed patient and noted that the perifix catheter connector has become disconnected at the epidural site. This perifix connector had been secured using the label or cloth tape correction recommendations set forth in b braun¿s medical device correction: (b)(4).
 
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Brand NamePERIFIX CATHETER CONNECTOR
Type of DeviceBRAUN MELSUNGEN AG (BBMAG) ANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
allentown PA
MDR Report Key7934242
MDR Text Key123060794
Report NumberMW5080348
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 Non-Healthcare Professional
Type of Report Initial
Report Date 09/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8451290
Device Lot NumberNOT AVAILABLE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
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: 10/03/2018 Patient Sequence Number: 1
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