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

Model Number	0.2 MCRN FLTR, ASV 25/BX
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that during pre-testing of this smiths medical cadd extension sets, the set did not allowed medication out.No reported adverse effects or patient injury.
Additional Manufacturer Narrative
One cadd extension set from p/n 21-7040-24, l/n; 3788326 was received in used condition without its original packaging.The sample was visually inspected at a distance of 12" under normal conditions of illumination.The sample had an occlusion in the bond between the luer an tube.Relevant documents were reviewed and deemed adequate and correct with respect to testing and inspection activities.The reported issue was able to be confirmed.The most probable cause of the issue is that there was excess solvent applied in the solvent bond.Production personnel were trained on solvent bond application in order to reinforce the solvent application.

• Brand Name: CADD EXTENSION SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 10211939
• Report Number: 3012307300-2020-06383
• Device Sequence Number: 2565262
• Product Code: FPA
• UDI-Device Identifier: 10610586020223
• UDI-Public: 10610586020223
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K942046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2020

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: No Information
• Device Expiration Date: 04/25/2024
• Device Model Number: 0.2 MCRN FLTR, ASV 25/BX
• Device Catalogue Number: 21-7040-24
• Device Lot Number: 3788326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/01/2020
• Supplement Date Received by Manufacturer: 11/22/2020
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 12/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1