MAUDE Adverse Event Report: ST PAUL CADD; INTRAVASCULAR ADMINISTRATION SET

Model Number 21-7302-24

Device Problem Defective Component (2292)

Patient Problem Insufficient Information (4580)

Event Date 07/20/2021

Event Type  malfunction  

Event Description

Information was received regarding a cadd cassette reservoir.It was reported that patient had issues with his cassettes not working properly.This occurred three times.Details of the disfunction was not provided.It is unknown if there was any patient, or clinician injury associated with this occurrence.No further details provided at this time.

• Brand Name: CADD
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 12411724
• MDR Text Key: 269532023
• Report Number: 3012307300-2021-09079
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027239
• UDI-Public: 10610586027239
• Combination Product (y/n): N
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 21-7302-24
• Device Catalogue Number: 21-7302-24
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1