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

Catalog Number	21-7375-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that during use of this smiths medical cadd administration sets, fluid leaked was noted.It was reported that the administration sets was used for hydration with tubing connected to an extension sets.According to the reports when the extension sets was connected, fluid leaked out of the needless access connector and around the luer connector of the extension set.However, when the extension set was removed, the fluid leaking stopped.No reported adverse effects.
Additional Manufacturer Narrative
Device evaluation: one cadd administration sets - flow stop was returned for analysis in used condition.Visual inspection identified a light crack was detected in the top view.During functional testing, a leak was observed fleeing from the connection.The customer reported issue was able to be duplicated.The most probable cause were identified as 1.The product became damaged after it left smiths medical facility.2.The product was received damaged from the supplier.

• 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: 8377678
• Report Number: 3012307300-2019-00927
• Device Sequence Number: 2977645
• Product Code: FPA
• UDI-Device Identifier: 10610586027444
• UDI-Public: 10610586027444
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K031361
• 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): 06/03/2019

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 Catalogue Number: 21-7375-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2019
• Supplement Date Received by Manufacturer: 05/06/2019
• Initial Report FDA Received Date: 02/28/2019
• Supplement Report FDA Received Date: 06/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1