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

Catalog Number	21-7083-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/27/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that during the use of a smiths medical cadd administration set, leak was noted at the filter.No patient injury was reported.No adverse events were reported.
Additional Manufacturer Narrative
Device evaluation: one smiths medical cadd administration set was returned for analysis.Visual inspection found no abnormalities.Leak testing was performed using hydrostat vessel to look for unusual functions and a leak was observed fleeing from the air vent of the filter in the sample.Based on the evidence, the complaint was confirmed and the problem source of the reported event is unknown.

• Brand Name: CADD ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8500661
• Report Number: 3012307300-2019-01495
• Device Sequence Number: 16843603
• Product Code: FPA
• UDI-Device Identifier: 10610586021527
• UDI-Public: 10610586021527
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K991301
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2019

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: 03/28/2023
• Device Catalogue Number: 21-7083-24
• Device Lot Number: 3604496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2019
• Supplement Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 04/10/2019
• Supplement Report FDA Received Date: 06/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1