MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. INF SET CLEO 42" 9MM; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21723224

Device Problem Filling Problem (1233)

Patient Problem Insufficient Information (4580)

Event Date 01/23/2021

Event Type  malfunction  

Event Description

Spontaneous call from patient having trouble getting her cleo tubing to properly fill when doing cartridge change.She had two malfunctions with the cleo tubing.The lot numbers are# 3965601 and # 4031119.The third one worked.No side effects for patient.No other info known.Reported to (b)(6) by pt/caregiver.

• Brand Name: INF SET CLEO 42" 9MM
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 11337583
• MDR Text Key: 232388704
• Report Number: MW5099423
• 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: 01/23/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 21723224
• Device Lot Number: 3965601
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR