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

Model Number	21-7045-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/17/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the use of the cadd extension set, the medication leaked.There were no adverse events reported.

• Brand Name: CADD
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 10128137
• Report Number: 3012307300-2020-05629
• Device Sequence Number: 13976639
• Product Code: FPA
• UDI-Device Identifier: 10610586020292
• UDI-Public: 10610586020292
• Combination Product (Y/N): N
• PMA/510(K) Number: K942046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/08/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/19/2023
• Device Model Number: 21-7045-24
• Device Lot Number: 3675044
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2020
• Initial Report FDA Received Date: 06/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1