MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD MS3 CARTRIDGE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7450-24

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 11/26/2019

Event Type  malfunction  

Event Description

Information was received indicating that during set-up of a smiths medical cadd ms3 cartridge, the reporter indicated that per patient, remodulin leakage was noted priming the tube.No adverse effects were reported.

Manufacturer Narrative

Device evaluation: one smiths medical cadd ms3 cartridge was returned for analysis.Visual inspection was performed under normal conditions of illumination.It was noted that the external component had a crack in the female luer.During analysis, the cozmo product was filled with water and connected to the returned product, and a leak was detected.Based on the evidence, the complaint was confirmed, and the problem source of the reported event is unknown.

• Brand Name: CADD MS3 CARTRIDGE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9519979
• MDR Text Key: 176484665
• Report Number: 3012307300-2019-07142
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586028694
• UDI-Public: 10610586028694
• Combination Product (y/n): N
• PMA/PMN Number: K051568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/11/2024
• Device Model Number: 21-7450-24
• Device Catalogue Number: 21-7450-24
• Device Lot Number: 3776281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Initial Date Manufacturer Received: 11/27/2019
• Initial Date FDA Received: 12/26/2019
• Supplement Dates Manufacturer Received: 02/06/2020
• Supplement Dates FDA Received: 03/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1