MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CLEO; ANESTHESIA CONDUCTION KIT

Model Number	21-7231-24
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.Product samples were received for evaluation.Visual and functional testing were performed.Visual inspection found the samples were received in used condition without its original packaging.It was observed that the cannula was broken in the unit returned.During a review of the manufacturing process, the line clearance record was reviewed; 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 trained on the operation that was performed.Site threader machine that is used for the operation and maintenance records was reviewed; no anomalies were detected.During functional testing of three retain samples, 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.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional investigative action will be taken.
Event or Problem Description
It was reported that the cannula was broken during removal.No patient injury was reported.

• Brand Name: CLEO
• Common Device Name: ANESTHESIA CONDUCTION KIT
• 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: 15591607
• Report Number: 3012307300-2022-23605
• Device Sequence Number: 19367164
• Product Code: FPA
• UDI-Device Identifier: 30610586028407
• UDI-Public: 30610586028407
• Combination Product (Y/N): N
• 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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2018
• 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