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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG PERIFIX ANESTHESIA CONDUCTION KIT

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B. BRAUN MELSUNGEN AG PERIFIX ANESTHESIA CONDUCTION KIT Back to Search Results
Device Problem Component Missing (2306)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/28/2019
Event Type  malfunction  
Event Description
Patient received an epidural for pain relief for a vaginal delivery. When it was time to take the epidural catheter out, at 1015, the tip was noted to be intact, but the blue paint to mark the tip was noted to be chipping off. The patient was informed and aware.
 
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Brand NamePERIFIX
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
B. BRAUN MELSUNGEN AG
901 marcon blvd.
allentown PA 18109
MDR Report Key8394004
MDR Text Key137976362
Report Number8394004
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 03/04/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/06/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/04/2019
Event Location No Information
Date Report to Manufacturer03/06/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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