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

Device Problem Difficult to Remove (1528)

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

Event Date 04/26/2018

Event Type  malfunction  

Manufacturer Narrative

This mdr was generated under protocol b10009704, as a result of warning letter cms# 617147.No lot number was provided; therefore, device history record review could not be completed.A product sample was received for evaluation.Visual and functional testing were performed.A broken cannula was detected with the returned sample.Three (3) samples of a different lot were taken from the production line and tested.After removing the white cap the site was inserted into the insertion pad.The inserted cannula was twisted around and pulled from the insertion pad, in neither of the worse test cases produced can cause the cannula to brake or detach.No detachment was detected in any of the tested samples and the cannula was not remove from the site.The root cause of the reported issue could not be confirmed at the time of the evaluation.A corrective and preventative action has been opened to perform a complete root cause analysis of the failure mode.A notification of this complaint to the production personnel was conducted by the quality engineer.(catalog number and udi) are unknown.No information has been provided to date.

Event Description

It was reported that the cannula embedded in patients abdomen during removal.No patient injury was reported.

• 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; minneapolis, MN 55442
• MDR Report Key: 15589939
• MDR Text Key: 306283092
• Report Number: 3012307300-2022-23552
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K042172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Female