MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Customer did not provide product information.

Event Description

Information was received regarding a cadd ms3 accessory.It was reported that the patient's cadd ms3 syringe either breaks or does not work.This occurred during the administration of continuous remodulin 2.5 mg/ml being administered at 20 ng/kg/min.No patient injury was reported.

• Brand Name: CADD
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 10960300
• MDR Text Key: 220466396
• Report Number: 3012307300-2020-12182
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Weight: 46