MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CLEO 90 SUBCUTANEOUS INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	21-7232-24
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device was returned.The following operations were reviewed, in order to verify that the operations were properly performed, also records were reviewed, in order to ensure that complied with gmp (good manufacturing practices) requirements and procedures: the assemble base with cannula to inserter operation was reviewed to ensure that the cannula is properly assembled; no discrepancies were found.Dispense ultraviolet adhesive, cure and inspected 100 percent operation for buckle ay was reviewed to ensure that adhesive is properly placed, no discrepancies were found.Training records were reviewed, operators are trained on operations been performed.A review of the production floor inventory was conducted, a sample of thirty-two units to ensure that the cannula and the base does not present any damage that could cause a leak.No discrepancies were found.During functional testing, four samples of the production floor inventory were taken to perform test.Buckle was connected to the base and a syringe was used to pass water through the tube.No leaks were detected during testing.Production personnel takes four units at the beginning of the shift, at the beginning of each batch, at least every three hours to perform the leak testing.Production personnel verifies 100 percent that parts not be damaged (including scratches) or distorted/warped.Quality control performs an in-process audit at one hour intervals to verify that needle is properly threaded on the retractor assemblies.Quality personnel verifies 100 percent that the needle tip is up and the blunt end is fully seated and verify the length while still in the needle hub on the pallet.Quality personnel will divide that the sample size so that a proportional amount is inspected at a one hourly interval to ensure that tubes have pass through the occlusion tester and that there is air flow above ten on the scale.No root cause could determine since the complaint could not be confirmed since no samples or pictures were received for evaluation.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
Event or Problem Description
It was reported that there was a leak between the tubing and the device right after the set's application.No patient injury reported.

• Brand Name: CLEO 90 SUBCUTANEOUS INFUSION SET
• 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: 15353929
• Report Number: 3012307300-2022-17728
• Device Sequence Number: 6323359
• Product Code: FPA
• UDI-Device Identifier: 30610586028414
• UDI-Public: 30610586028414
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K042172
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/04/2022

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
• Device Expiration Date: 07/10/2024
• Device Model Number: 21-7232-24
• Device Catalogue Number: 21-7232-24
• Device Lot Number: 3844267
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 09/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2019
• 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 Age: 67 YR
• Patient Sex: Female