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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN PERIFIX FX

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B. BRAUN PERIFIX FX Back to Search Results
Model Number 332097
Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/13/2018
Event Type  Injury  
Event Description
While placing epidural, 3/4cm of tip of catheter broke off and was unaccounted for.
 
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Brand NamePERIFIX FX
Type of DevicePERIFIX FX
Manufacturer (Section D)
B. BRAUN
bethlehem PA 18018
MDR Report Key7457643
MDR Text Key106700914
Report NumberMW5076685
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 Other Health Care Professional
Type of Report Initial
Report Date 04/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2019
Device Model Number332097
Device Catalogue NumberCE17TKFCS
Device Lot Number0061588414
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: 04/24/2018 Patient Sequence Number: 1
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