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

Model Number 21-7052-24

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

Patient Problem Discomfort (2330)

Event Date 11/11/2020

Event Type  malfunction  

Event Description

Information was received indicating that during use, a smiths medical cadd extension set leaked a blincyto solution.Subsequently, the set was changed.No adverse effects were reported other than patient discomfort.

• 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: 11337295
• MDR Text Key: 232164727
• Report Number: 3012307300-2021-01287
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586020346
• UDI-Public: 10610586020346
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K974013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 21-7052-24
• Device Catalogue Number: 21-7052-24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/19/2021
• 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