MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. INF SET CLEO 42" 6MM; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21722224

Device Problem Material Twisted/Bent (2981)

Patient Problem Pain (1994)

Event Date 09/01/2022

Event Type  Injury  

Event Description

Remodulin sq with ms3 patients previous site was placed about two weeks ago but patient was experiencing a lot of leg pain.They spoke to md and they were advised to change site.Father added it appeared as though the cannula may have been bent.No other information available.Product lot number and expiration date were systematically retrieved from the dispensing system.Reported to (b)(6) by pt/caregiver.

• Brand Name: INF SET CLEO 42" 6MM
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 15606032
• MDR Text Key: 301933641
• Report Number: MW5112627
• 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: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 21722224
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 14 YR
• Patient Sex: Male