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

Model Number	21-7231-24
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the sett up of the catheter, the adhesive diaphragms remained stuck to the patient's belly.The needle remained in the patient's skin.No medical or surgical intervention was reported.
Additional Manufacturer Narrative
This mdr was generated under protocol b10009704 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 the sample was received in used condition without its original packaging.It was observed that the sample has the retractor active and without the needle in the retractor.During a review of the production run, the needle assembly operation was audited and it was performed by the production personnel according to the manufacturing procedures.Training records were reviewed; operators were trained on the operation been performed.Maintenance records from the machine used for the operation were reviewed; no anomalies were detected.During functional testing, no discrepancies were found.The sample was also checked to confirm that it had adhesive, comparing it with a piece of raw material without adhesive.When comparing both samples, it was observed that a piece with adhesive forms a conical part in the upper part of the component.The retractor assemblies are one hundred percent visually inspected by the production personnel to assure that the needle is properly threaded.Production personnel verifies one hundred percent that parts not be damaged (including scratches) or distorted/warped.The root cause of the reported issue was found to be the adhesive was not placed correctly.An alert was generated to ensure that operators verify that the amount of adhesive drop is correct and that it is placed as indicated in the procedure.Production personnel was also retraining to the on procedure to reinforce the needle bonding operation.(510k) is unknown.No product information has been provided to date.

• Brand Name: CLEO
• 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: 15591688
• Report Number: 3012307300-2022-23612
• Device Sequence Number: 16710017
• Product Code: FPA
• UDI-Device Identifier: 30610586028407
• UDI-Public: 30610586028407
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• 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 Expiration Date: 12/04/2022
• Device Model Number: 21-7231-24
• Device Catalogue Number: 21-7231-24
• Device Lot Number: 77X187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2018
• 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