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

Catalog Number	21-7231-24
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, that the device had a leakage.And the patient did not receive his daily dose of treatment, and this led to blockages.No patient injury reported.
Additional Manufacturer Narrative
D5 and e4 are unknown.No further information has been provided.This remediation mdr was generated under protocol b10010116, as a result of warning letter cms# (b)(6).No problems or issues were identified during this device history record review.Sample received: one (1) sample was received in used condition without its original package.Functional testing: cannula was connected to retractor, and then we tested using a syringe with water to detect leaks.The water passed through the connector.We did not observe leaks or occlusion in the assembly.The complaint was not confirmed.Based on the analysis conducted in the sample provided, the complaint was not confirmed, root cause could not be determined.No corrective actions were taken since the complaint was not confirmed.

• 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): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16902788
• Report Number: 3012307300-2023-05465
• Device Sequence Number: 6837398
• Product Code: FPA
• UDI-Device Identifier: 10610586028403
• UDI-Public: 10610586028403
• 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): 05/10/2023

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: 10/03/2025
• Device Catalogue Number: 21-7231-24
• Device Lot Number: 4062387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2023
• Initial Report FDA Received Date: 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2020
• 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: 73 YR
• Patient Sex: Female