MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC CADD ADMINISTRATION SET- FLOW STOP; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 21-7359-24

Device Problem Pressure Problem (3012)

Patient Problem No Information (3190)

Event Date 10/01/2019

Event Type  malfunction  

Event Description

Information was received indicating that there was an occlusion when trying to prime the cadd administration set.There was no reported injury or adverse events.

Manufacturer Narrative

The event date is unknown.

• Brand Name: CADD ADMINISTRATION SET- FLOW STOP
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9263193
• MDR Text Key: 164515975
• Report Number: 3012307300-2019-05154
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027406
• UDI-Public: 10610586027406
• Combination Product (y/n): N
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/09/2023
• Device Catalogue Number: 21-7359-24
• Device Lot Number: 3712544
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1