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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BRAUN BRAUN EXTENSION TUBING

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BRAUN BRAUN EXTENSION TUBING Back to Search Results
Model Number NOT AVAILABLE
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/11/2016
Event Type  malfunction  
Event Description
Braun extension needed to be replaced on several pts. The tubing often did not allow fluids to run free flow when needed. It often will not allow piggyback fluids to run. The tubing had to be changed on several pts. The iv pump was first replaced to r/o pump failure. No pt data available.
 
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Brand NameBRAUN EXTENSION TUBING
Type of DeviceEXTENSION TUBING
Manufacturer (Section D)
BRAUN
bethlehem PA 18018
MDR Report Key5910159
MDR Text Key53555766
Report NumberMW5064389
Device Sequence Number1
Product Code OJA
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 08/24/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/24/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNOT AVAILABLE
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
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?
Type of Device Usage

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