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

Catalog Number	21-7232-24
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that infusion device placed on top of tegaderm has come off, with the plate of the infusion device separating from the white sticky tape/dressing under the plate.This was the fourth time there were issues with the infusion device coming off the patient's skin, raising the question whether the glue on the infusion port was adequate.The patient replaced the device and restarted the infusion.No patient harm/adverse event was reported.
Additional Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
D4: primary udi number; corrected.H6.Evaluation codes: updated.No product or photos were returned therefore no device analysis could be completed.A device history record (dhr) review showed there were no discrepancies or non-conformances during the manufacturing of the reported lot number.If the product is returned the manufacturer will re-open the complaint for further device analysis.

• Brand Name: CLEO
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL MD, INC.; 6000 nathan lane n; tijuana MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19509806
• Report Number: 3012307300-2024-04815
• Device Sequence Number: 16992778
• Product Code: FPA
• UDI-Device Identifier: 30610586028414
• UDI-Public: (01)30610586028414(17)271207(10)4349019
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K042172
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2024

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: Lay User/Patient
• Device Catalogue Number: 21-7232-24
• Device Lot Number: 4349019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2024
• Supplement Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/21/2022
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TEGADERM
• Patient Age: 69 YR
• Patient Sex: Unknown