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

Model Number	21-7081-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event occurred in (b)(6) but was reported by the u.S site.Related mfr numbers are : 3012307300-2019-06192, 3012307300-2019-06193.
Event or Problem Description
Information was received indicating that the cadd administration set leaked was found leaking during infusion.The leak was noticed from the stinging cap of the "y".There was no reported injury to the patient.
Additional Manufacturer Narrative
One cadd administration set was returned for analysis.The sample was observed to be cut from the tube connection injection site upon visual inspection.The tubing was leak tested; no discrepancies found.The manufacturing process was reviewed; no discrepancies noted.Based on the evidence, there was no fault found as the complaint was not confirmed.

• 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: 9292707
• Report Number: 3012307300-2019-06191
• Device Sequence Number: 14065481
• Product Code: FPA
• UDI-Device Identifier: 10610586021480
• UDI-Public: 10610586021480
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K991599
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2020

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: Health Professional
• Device Model Number: 21-7081-24
• Device Catalogue Number: 21-7081-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2019
• Supplement Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 11/07/2019
• Supplement Report FDA Received Date: 04/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1