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

Catalog Number	21-7036-01
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report source: (b)(6).
Event or Problem Description
Information was received that the cadd extension set tubing was leaking at the distal end of cassette as soon as tubing was attached to patient.No reported adverse effects.
Additional Manufacturer Narrative
The cadd administration set was returned for analysis.Leak testing on the sample received were performed using hydrostat vessel to look for unusual functions.A leak was observed fleeing from the bonding between the tubing 12" and pump tube.The manufacturing process is being reviewed in order to verify that there are no situations or practices that could create the event described.

• Brand Name: CADD EXTENSION SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8360704
• Report Number: 3012307300-2019-00640
• Device Sequence Number: 1959276
• Product Code: FPA
• UDI-Device Identifier: 10610586020186
• UDI-Public: 10610586020186
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K933390
• 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,Followup
• Report Date (Section B): 04/30/2019

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: 07/19/2023
• Device Catalogue Number: 21-7036-01
• Device Lot Number: 3674617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2019
• Supplement Date Received by Manufacturer: 03/31/2019
• Initial Report FDA Received Date: 02/21/2019
• Supplement Report FDA Received Date: 04/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1