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

Catalog Number	21-7605-24
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other text: d4: lot number, expiration date is unknown; h4: unknown.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported the disposable's medicinal solution does not flow.Patient involvement is unknown.
Additional Manufacturer Narrative
Two photos were provided, and one sample was received for evaluation.Visual inspection found no obstructions, damage, or other defects detected.To conduct functional testing a disposable was set up with a pump and ran.Upon testing, there were no abnormalities observed while running the sample, no alarms were activated, thus the failure mode reported is not confirmed.No lot numbers were provided; therefore, device history record (dhr) reviews could not be conducted.

• Brand Name: CADD EXTENSION SETS NRFIT
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17654739
• Report Number: 3012307300-2023-08533
• Device Sequence Number: 15024213
• Product Code: LHI
• UDI-Device Identifier: 10610586044113
• UDI-Public: 10610586044113
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K162219
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2023

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: Health Professional
• Device Catalogue Number: 21-7605-24
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/18/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2023
• Supplement Date Received by Manufacturer: 10/09/2023
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown