MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CLEO; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	21-7232-24
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient called the emergency line regarding tubing issue, the tubing was cut and almost separated into two pieces.The customer immediately changed to a new tubing and started the infusion.There was no changes in breathing, chest pain or any other symptoms: no patient injury was reported.
Additional Manufacturer Narrative
No product was returned, thus the failure mode reported was not confirmed and a root cause could not be determined.There are no lot or serial number was provided therefore; no device history record (dhr) could be completed.Operator of device: patient or consumer.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: CLEO
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15393847
• Report Number: 3012307300-2022-18350
• Device Sequence Number: 6198143
• Product Code: FPA
• UDI-Device Identifier: 30610586028414
• UDI-Public: 30610586028414
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K042172
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2022

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
• Operator of Device: Lay User/Patient
• Device Model Number: 21-7232-24
• Device Catalogue Number: 21-7232-24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2022
• Initial Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown