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

Model Number	21-7062-24
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign report source: (b)(6).
Event or Problem Description
Information was received indicating that a smiths medical cadd extension set may have under-infused.It was reported an unspecified amount of medical fluid remained in the cadd medication cassette.No adverse patient effects were reported.
Additional Manufacturer Narrative
One cadd extension set was received for evaluation.Visual inspection of the device found it to be in good physical condition.Device underwent functional testing; customer complaint was not confirmed.Additionally, four samples from inventory underwent functional testing; devices functioned as intended.

• Brand Name: CADD EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9666673
• Report Number: 3012307300-2020-00960
• Device Sequence Number: 10842699
• Product Code: FPA
• UDI-Device Identifier: 10610586020452
• UDI-Public: 10610586020452
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K942046
• 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): 06/01/2020

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: 04/20/2024
• Device Model Number: 21-7062-24
• Device Catalogue Number: 21-7062-24
• Device Lot Number: 3780634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2019
• Supplement Date Received by Manufacturer: 03/20/2020
• Initial Report FDA Received Date: 02/04/2020
• Supplement Report FDA Received Date: 06/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1