MAUDE Adverse Event Report: ST PAUL CLEO 90 SUBCUTANEOUS INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Skin Discoloration (2074)

Event Date 01/28/2020

Event Type  malfunction  

Event Description

It was reported that, with use of the device, a discoloration was noted at the infusion site.No medical or surgical intervention was reported.

Manufacturer Narrative

No device was returned.The following operations were reviewed, in order to verify that the operations were properly performed, also records were reviewed, in order to ensure that complied with gmp (good manufacturing practices) requirements and procedures: the assemble base with cannula to inserter operation was reviewed to ensure that the cannula is properly assembled; no discrepancies were found.The operators that perform critical operations such as bond skin adhesive film onto flange of sleeve and the skin adhesive inspections using a monitor are certified.The operator performs the visual inspection of the adhesive using the skin adhesive inspection.Four samples from reported lot number were taken from production floor and tested for in-process testing and no discrepancies were found.Visual inspection of thirty-two samples from a different lot number were taken from production line and were visually inspected in order to verify that the spring is not released.Results: no discrepancies were detected.The retractor assemblies were 100 percent visually inspected by the production personnel to assure that the needle is properly threaded.Production personnel verified 100 percent that parts were not damaged (including scratches) or distorted/warped.Quality personnel verifies 100 percent that the needle tip is up, and the blunt end is fully seated and verify the length while still in the needle hub on the pallet.No root cause could be determined, as no samples or pictures were received for evaluation.No corrective actions are required since the complaint could not be confirmed.A device history record (dhr) review was performed.No problems or issues were identified during the dhr review.No product information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: CLEO 90 SUBCUTANEOUS INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; im einsatz uber agap2; minneapolis, MN 55442
• MDR Report Key: 15353838
• MDR Text Key: 305373950
• Report Number: 3012307300-2022-17651
• Device Sequence Number: 1
• Product Code: FPA
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1