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

Model Number	21-7339-24
Medical Device Problem Codes	Insufficient Flow or Under Infusion (2182); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/18/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that a smiths medical cadd administration set was not delivering medication.The reporter indicated that per nurse, the patient had not received any medication for hours.Subsequently, the tubing was changed out then medication was able to be infused without an issue.No patient consequences were reported.No adverse effects were reported.
Additional Manufacturer Narrative
Additional information: four pictures were received; no discrepancies are visible related to the issue reported.One sample was received for evaluation.Visual inspection of the pump found a kink on the pump tube.The device then underwent functional testing-was connected to a hydrostat vessel.Fluid noted to pass through with some resistance.Once connected again to the pump, it could be primed without difficulty.No discrepencies were detected-whole set able to be primed.The reported customer complaint was unable to be confirmed.

• Brand Name: CADD ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis, mn
• MDR Report Key: 10080244
• Report Number: 3012307300-2020-04691
• Device Sequence Number: 3468588
• Product Code: FPA
• UDI-Device Identifier: 10610586027307
• UDI-Public: 10610586027307
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K040636
• 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): 07/06/2020

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: 03/09/2025
• Device Model Number: 21-7339-24
• Device Catalogue Number: 21-7339-24
• Device Lot Number: 3955203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2020
• Supplement Date Received by Manufacturer: 06/07/2020
• Initial Report FDA Received Date: 05/21/2020
• Supplement Report FDA Received Date: 07/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Weight: 76