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

Model Number	21-7231-24
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Skin Discoloration (2074); Skin Inflammation/ Irritation (4545)
Date of Event	01/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4) as a result of warning letter cms# 617147.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.Visual inspection found that the cannula was broken.During a review of the production run, the line clearance record was reviewed and there were no discrepancies were observed.The inserter assembly operation was audited and it was performed by the production personnel according to the manufacturing procedures.Training records were reviewed and the operators were e trained on operation been performed.Maintenance records from the site threader machine was reviewed and no anomalies were detected.Three samples from the production line were tested and 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 control 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.
Event or Problem Description
It was reported that the catheter top broke off and remained in the skin and encapsulated.An cherry-green, bluish-red discoloration / inflammation around a broken teflon sheath (flexible needle) of catheter.When attempting to remove the catheter as usual after suspending the infusion pump, it broke off and has since been left in the subcutis in the area of the right shoulder.No medical or surgical intervention was reported.

• 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): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15591540
• Report Number: 3012307300-2022-23598
• Device Sequence Number: 16726489
• Product Code: FPA
• UDI-Device Identifier: 30610586028407
• UDI-Public: 30610586028407
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K042172
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/12/2022

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: Health Professional
• Device Model Number: 21-7231-24
• Device Catalogue Number: 21-7231-24
• Device Lot Number: 6FN169B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2022
• Initial Report FDA Received Date: 10/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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