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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMEDIXWAI BIOMEDIXWAI SET, ADMINISTRATION, INTRAVASCULAR

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BIOMEDIXWAI BIOMEDIXWAI SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number SELEC-3 IV ADMIN SET
Device Problem Defective Component (2292)
Patient Problem Death (1802)
Event Date 07/05/2020
Event Type  Death  
Event Description
During the course of patient care the iv tubing medication port was found to be defective. Provider was unable to administer medication for a patient during cardiac arrest. The tubing in question was verified to be defective. Multiple sets from the same lot number were found to be defective. Fda safety report id# (b)(4).
 
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Brand NameBIOMEDIXWAI
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BIOMEDIXWAI
3895 west vernal pike
IN 47404
MDR Report Key10282519
MDR Text Key199242713
Report NumberMW5095538
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 07/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSELEC-3 IV ADMIN SET
Device Lot Number002074
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: 07/15/2020 Patient Sequence Number: 1
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