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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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Type of DevicePERIFIX FX
Manufacturer (Section D)
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