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

Catalog Number	21-7083-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that during use of this smiths medical cadd administration sets, leaking from the filter area of the tubing was noted.It was reported that patient was receiving chemotherapy at home at approximately 41cc/hr.No clinical injury and no reported adverse effects.
Additional Manufacturer Narrative
One cadd administration set was received for analysis.The sample was visually inspected, at a distance of 12" to 24" at normal conditions of illumination, delamination was found in both joins of the filter with the tube in.Leak testing on one of the samples received was performed using hydrostat vessel to look for unusual functions.A leak was observed fleeing from the air vent of the filter which confirm the defect.A review of the manufacturing process was performed in order to verify that there are no situations or practices that could create the reported event.No discrepancies were found, quality personnel verify that tests are properly performed.

• 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: 8502312
• Report Number: 3012307300-2019-01493
• Device Sequence Number: 1436227
• 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: distributor,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2019

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: 06/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1