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

Model Number 21-7302-24

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 01/31/2021

Event Type  malfunction  

Event Description

It was reported the device leaked fluid.

• Brand Name: CADD
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11406037
• MDR Text Key: 234496036
• Report Number: 3012307300-2021-01701
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027239
• UDI-Public: 10610586027239
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2021
• 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
• Device Lot Number: 4046847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1