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

Model Number	21-7386-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received regarding a cadd administration set.It was reported that the device leaked.This occurred during infusion; effect on patient is unknown.

• Brand Name: CADD
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 11734928
• Report Number: 3012307300-2021-03488
• Device Sequence Number: 4219960
• Product Code: FPA
• UDI-Device Identifier: 15019517161977
• UDI-Public: 15019517161977
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K031361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/27/2021

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: No Information
• Device Expiration Date: 01/30/2025
• Device Model Number: 21-7386-24
• Device Catalogue Number: 21-7386-24
• Device Lot Number: 3932730
• 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: 03/30/2021
• Initial Report FDA Received Date: 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1