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

Catalog Number 21-7221-24

Device Problem Patient Device Interaction Problem (4001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/15/2021

Event Type  malfunction  

Manufacturer Narrative

This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.No problems or issues were identified during this device history record review.A product sample was received for evaluation.Visual and functional testing were performed.Sample received: one (1) sample was received decontaminated condition without its original package.Functional testing: cannula was connected to retractor and then we tested using a syringe with water to detect any occlusion.Results: occlusion was found in the returned sample.The complaint was confirmed.The root cause of the reported issue was found to be due to an occlusion.Actions were taken to mitigate the reported issue: a scar was opened with the supplier.

Event Description

It was reported that the patient placed the catheter in the evening.Insulin was delivered but after 1.5 h, the patient had a blood glucose value of 200 mg.Afterwards, another bolus was delivered, then had a value of 300 mg.The patient removed the catheter and reconnected to the insulin pump and delivered test units of insulin.No insulin came out of the cannula.No patient injury was reported.

• Brand Name: CADD CLEO INFUSION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16910007
• MDR Text Key: 314976376
• Report Number: 3012307300-2023-05529
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586028342
• UDI-Public: 10610586028342
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K042172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 21-7221-24
• Device Lot Number: 3984448
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1