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

Model Number 21723024

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Patient requested to send 2-3 extra tubing¿s with this order.Patient reported there was an issue with one of his previous tubing¿s and he had to replace it.Pt did not report any side effects.No missed dose or adverse event reported due to the issue with the tubing.Subq remunity self-fill patient.Defective product lot number and expiration date are unknown.Unknown if pt has the defective product on hand for possible return to the manufacturer.No further details provided.Reported to (b)(6) by: patient/caregiver.

• Brand Name: INF SET CLEO 24" 9MM
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 17228054
• MDR Text Key: 318289734
• Report Number: MW5118949
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• 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: 06/23/2023

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 Model Number: 21723024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/28/2023
• Patient Sequence Number: 1
• Patient Sex: Male