MAUDE Adverse Event Report: CAREFUSION, 303, INC. BD ALARIS PUMP INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 2420-0007

Device Problems Defective Component (2292); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/16/2019

Event Type  malfunction  

Event Description

Pt tubing was being set up and tubing primed.When tubing primed, tubing ballooned out.Tubing was not used on the pt.Fda safety report id# (b)(4).

• Brand Name: BD ALARIS PUMP INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION, 303, INC. ; san diego CA
• MDR Report Key: 9098191
• MDR Text Key: 159708111
• Report Number: MW5089926
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/05/2022
• Device Catalogue Number: 2420-0007
• Device Lot Number: 19073076
• 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 Age: 67 YR