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

Catalog Number	21-7232-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This remediation mdr was generated under protocol b10010116, as a result of warning letter cms#(b)(6).No problem or issues were identified during the device history record review.The reported issue could not be confirmed, as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.
Event or Problem Description
It was reported, that there was leakage observed from catheter.No patient injury 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): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16900154
• Report Number: 3012307300-2023-05443
• Device Sequence Number: 5359832
• Product Code: FPA
• UDI-Device Identifier: 10610586028410
• UDI-Public: 10610586028410
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K042172
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• 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
• Operator of Device: Health Professional
• Device Catalogue Number: 21-7232-24
• Device Lot Number: 4082956
• 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: 05/03/2023
• Initial Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2020
• 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 Sex: Unknown