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

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).

• Brand Name: BIOMEDIXWAI
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BIOMEDIXWAI; 3895 west vernal pike; IN 47404
• MDR Report Key: 10282519
• MDR Text Key: 199242713
• Report Number: MW5095538
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 07/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SELEC-3 IV ADMIN SET
• Device Lot Number: 002074
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 54 YR
• Patient Weight: 81