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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTRAVENOUS EXTENSION TUBING SET

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INTRAVENOUS EXTENSION TUBING SET Back to Search Results
Device Problem Disconnection (1171)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/11/2020
Event Type  malfunction  
Event Description
Patient's mom called out when she noted something was wet under iv tubing. Iv tubing became disconnected between filter and trifuse.
 
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Type of DeviceINTRAVENOUS EXTENSION TUBING SET
MDR Report Key9646631
MDR Text Key176960391
Report Number9646631
Device Sequence Number1
Product Code OJA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/23/2020
Event Location Hospital
Date Report to Manufacturer01/30/2020
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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