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 : 3012307300-2019-06190, 3012307300-2019-06187, 3012307300-2019-06188.
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.
Event or Problem Description
Investigation results completed on a smiths medical ambulatory infusion pumps|cadd administration sets - non flow stop.
Additional Manufacturer Narrative
Investigation completed on a smiths medical ambulatory infusion pumps|cadd administration set.Sample arrived and visually inspected from 12'-16' with a cut from the tube connected to injection site of male luer.When testing was done to verify complaint, no discrepancies were detected or found.Testing with syringe to verify leak also did not confirm, as device passed.Quality engineer testing during manufacturing no discrepancies were found.Root cause was not established and no device malfunction was detected.Preventative action taken to notify supplier on 21-may-2019 as awareness of the defect reported by the customer.

• 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: 9292708
• Report Number: 3012307300-2019-06189
• Device Sequence Number: 11270295
• 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): 04/24/2020

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: 11/20/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2019
• Supplement Date Received by Manufacturer: 10/22/2019
• Initial Report FDA Received Date: 11/07/2019
• Supplement Report FDA Received Date: 04/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1