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

Catalog Number	21-7222-24
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Hyperglycemia (1905)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cap on the kit is crooked, so insulin leaked out instead of into the subcutaneous fat tissue.This occurred at night after the user had to change a catheter due to kinking resulting in high blood glucose, so this severe hyperglycemia continued for several hours.The user was able to correct it but stated a less experienced user would probably have had to go to a hospital or emergency room.No medical or surgical intervention was reported.
Additional Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#(b)(4).No problem or issues were identified during the device history record review.Two pictures were received for evaluation.In the attached pictures it is not possible to see the reported defect.The complaint is not confirmed.During manufacturing, there are checks in process to assure this defect does not occur.Based on the analysis conducted in the picture provided, the complaint was not confirmed.No corrective actions were taken.

• Brand Name: CADD CLEO INFUSION SETS
• Common Device Name: 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: 16892125
• Report Number: 3012307300-2023-05365
• Device Sequence Number: 17631476
• Product Code: FPA
• UDI-Device Identifier: 10610586028359
• UDI-Public: 10610586028359
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K042172
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/08/2023

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/20/2025
• Device Catalogue Number: 21-7222-24
• Device Lot Number: 3984449
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 05/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2020
• 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