MAUDE Adverse Event Report: NULL CADD CLEO INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Fatigue (1849); Nausea (1970); Pain (1994); Dizziness (2194)

Event Date 10/30/2021

Event Type  malfunction  

Manufacturer Narrative

Udi and catalog information are unknown.Manufacturing site address is unknown.Premarket (510k) number is 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 Description

Per a social media search, it was reported that the patient had been put on treprostinil medication, sold under the brand name remodulin for infusion.Patient was wondering if anyone else had been on this medication and what are major side effects to watch out for? patient reported getting a lot of body ache, tiredness and weird nausea.

Manufacturer Narrative

Other text: no product was returned.We are unable to confirm the reported complaint.If the product is returned, smiths medical will reopen this complaint for further investigation.No lot number was provided; therefore, a device history record (dhr) review could not be conducted.

• Brand Name: CADD CLEO INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section G): NULL
• MDR Report Key: 16137199
• MDR Text Key: 308480081
• Report Number: 3012307300-2023-00343
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/28/2023

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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/17/2022
• Initial Date FDA Received: 01/11/2023
• Supplement Dates Manufacturer Received: 06/26/2023
• Supplement Dates FDA Received: 06/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1