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

Catalog Number 21-7231-24

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Pain (1994); Skin Discoloration (2074)

Event Date 03/06/2018

Event Type  malfunction  

Manufacturer Narrative

Other, other text: this mdr was generated under protocol (b)(4) as a result of warning letter cms# (b)(4).A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Product samples were received for evaluation.Visual and functional testing were performed.Visual inspection found one sample was received in unused condition its original packaging and one base with cannula within its original packaging.It was observed that the cannula was broken.During functional testing of the unused sample, no detachment was detected and the cannula was not removed from the site.During a review of the production run, line clearance record was reviewed; no discrepancies were observed.Inserter assembly operation was audited and it was performed by the production personnel according to the manufacturing procedures.Training records were reviewed, operators are trained on operation been performed.Maintenance records form site threader machine used for the operation were reviewed; no anomalies were detected.Three samples were taken from the production line and tested; no detachment was detected in any of the tested samples and the cannula was not removed from the site.The retractor assemblies are one hundred percent visually inspected by the production personnel to assure that the needle is properly threaded.Quality performs an in process audit at one hour intervals to verify that needle is properly threaded on the retractor assemblies.The root cause of the issue could not be determined.A corrective and preventative action has been opened to address the reported issue.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional investigative action will be taken.(udi) is unknown.No product information has been provided to date.

Event Description

It was reported that the cannula has remained embedded in the patient's skin.Patient was attempting to remove cannula per usual practice.Patient reported that the area where the cannula appears to be embedded in the skin is red and sore.No medical or surgical intervention was reported.

• Brand Name: CLEO INFUSION SETS
• 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: 15591614
• MDR Text Key: 304829502
• Report Number: 3012307300-2022-23600
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K031361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• 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: Lay User/Patient
• Device Expiration Date: 08/09/2022
• Device Catalogue Number: 21-7231-24
• Device Lot Number: 77X118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/30/2022
• 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: 60 YR
• Patient Sex: Female