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 : 3012307300-2019-06191, 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
H2: additional information: see d10.H3: one cadd administration set from p/n 21-7081-24 l/n unknown was received inside a plastic bag without its original packaging.The sample was visually inspected at a distance of 12" to 16" under normal conditions of illumination.The sample was received cut from the tube connected to injection site to the male luer.Leak testing on the sample received was performed using a syringe to look for unusual functions.No discrepancies were detected; the test successfully passed.The cause of the issue could not be determined since there was no fault found with the returned product.

• 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: 9292710
• Report Number: 3012307300-2019-06192
• Device Sequence Number: 2172677
• 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): 04/28/2020

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: 01/23/2020
• Initial Report FDA Received Date: 11/07/2019
• Supplement Report FDA Received Date: 04/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1