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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL, INC. PERIFIX FX EPIDURAL ANESETHISA TRAY EPIDURAL ANESTHESIA KIT

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B. BRAUN MEDICAL, INC. PERIFIX FX EPIDURAL ANESETHISA TRAY EPIDURAL ANESTHESIA KIT Back to Search Results
Device Problem Loose or Intermittent Connection (1371)
Patient Problem Pain (1994)
Event Date 03/01/2019
Event Type  malfunction  
Event Description
Pt had epidural for pain control in labor, clear clamp came undone from epidural catheter and patient became painful. Anesthesia notified and replaced clamp. Device: perifix fx epidural anesthesia tray.
 
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Brand NamePERIFIX FX EPIDURAL ANESETHISA TRAY
Type of DeviceEPIDURAL ANESTHESIA KIT
Manufacturer (Section D)
B. BRAUN MEDICAL, INC.
901 marcon blvd.
allentown PA 18109
MDR Report Key8711532
MDR Text Key148416392
Report Number8711532
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 06/12/2019,06/07/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/12/2019
Event Location Hospital
Date Report to Manufacturer06/19/2019
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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