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

Model Number	21-7375-24
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that with in use with a patient, a smiths medical cadd administration set had air bubbles form.No patient injury resulted.

• Brand Name: SMITHS MEDICAL CADD ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane n; minneapolis, mn
• MDR Report Key: 9925435
• Report Number: 3012307300-2020-02562
• Device Sequence Number: 11618805
• Product Code: FPA
• UDI-Device Identifier: 10610586027444
• UDI-Public: 10610586027444
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K031361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/03/2020

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: 10/23/2023
• Device Model Number: 21-7375-24
• Device Catalogue Number: 21-7375-24
• Device Lot Number: 3714265
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 04/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1