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

Catalog Number	21-2131-01
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: one device was returned.A visual inspection found the device in unused condition.During the functional testing, no device problem was able to be confirmed.The module was operating as intended.No problem found with the wireless connectivity functions of the comm module.Item is a purchased finished good, dhr is at the supplier.
Event or Problem Description
It was reported that the cadd solis communication module gives intermittent error.The product fault occurred immediately on use.There was no patient involvement and no patient harm/adverse reported.

• Brand Name: CADD COMMUNICATION MODULE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20800380
• Report Number: 3012307300-2024-14189
• Device Sequence Number: 6933317
• Product Code: FPA
• UDI-Device Identifier: 15019517173864
• UDI-Public: (01)15019517173864(17)250114(10)19081296
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K170982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/27/2024

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 Expiration Date: 01/14/2025
• Device Catalogue Number: 21-2131-01
• Device Lot Number: 19081296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2024
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown