MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. INF SET CLEO 24" 9MM; SET, ADMINISTRATION, INTRAVASCULAR

Patient Problems Pain (1994); Dizziness (2194); Unspecified Respiratory Problem (4464)

Event Type  Injury  

Event Description

Last site placed: (b)(6) 2024.Pt reports they are experiencing site pain, now 4 out of 10 today.Pt uses lidocaine patches, tylenol as needed and increased their anti-histamines pepcid, claritin and zyrtec during the time frame after first placing site and states this helps.Pt reports ongoing lightheadedness and ongoing nasal congestion; start dates unknown.Pt reports both symptoms are not new and md is aware.Pt also reports that last week they were connecting the tubing to the cassette and the tubing broke apart and was hanging down on the cassette side.Pt reports they noticed this within minutes and was able to change tubing and infusion was not interrupted.No adverse event reported from this event.Pt was unable to provide the lot number and expiration date of tubing but states the product is from their last refill.Did the reported product fault occur while in use with the pt? yes; did the product issue cause or contribute to pt or clinical injury? no; is the actual product available for investigation? unk; did pharmacy replace the product? yes; did the pt have a backup they were able to switch to? yes.No add'l info, details, or dates available.This is a continuous infusion; setflow rate and volume delivered are unk.Position of the pump when alarm occurred is not applicable as no pump alarm was reported.Pump return tracking info is not applicable as no pump issue was reported.Photographs were not provided.Sq remunity pharmacy fill pt.Pt started using remunity device (b)(6) 2024.Reported to (b)(6) by pt/caregiver.

• Brand Name: INF SET CLEO 24" 9MM
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 18846160
• MDR Text Key: 337156800
• Report Number: MW5152336
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: C-TREPROSTINIL(3ML)RM; OPSUMIT; TADALAFIL
• Patient Sex: Female