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

Catalog Number	21-7339-24
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
Information was received that the cadd administration set for a pump tubing was leaking at the filter.No reported adverse effects.
Additional Manufacturer Narrative
One cadd administration sets was returned for analysis.The samples were visually inspected at a distance of 12" to 24" under normal conditions of illumination.The samples received were visually inspected and no abnormality were detected.Leak testing on the samples received were performed using hydrostat vessel to look for unusual functions; no leaks were detected, successfully passed.Due to the fact there was no lots for p/n 21-7339-24 programed to be manufactured in the near future, per previous complaints a review of the manufacturing process for p/n 21-7359-24 l/n 3730590 was conducted by quality engineer on 12-nov-2018, in order to verify that there are no situations or practices that could create the event as described "leak at the filter".Root cause cannot be determined since the complaint was not confirmed due to the fact the sample successfully passed testing.No corrective actions are required since the complaint was not confirmed.However, production personnel were notified by quality engineer on 12-nov-2018 as awareness of the defect reported by the customer.

• Brand Name: CADD ADMINISTRATION SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8097001
• Report Number: 3012307300-2018-08470
• Device Sequence Number: 2745927
• Product Code: FPA
• UDI-Device Identifier: 10610586027307
• UDI-Public: 10610586027307
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K040636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2019

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: 03/03/2023
• Device Catalogue Number: 21-7339-24
• Device Lot Number: 3583213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2018
• Supplement Date Received by Manufacturer: 01/21/2019
• Initial Report FDA Received Date: 11/21/2018
• Supplement Report FDA Received Date: 02/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1