MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CLEO INSULIN SET, 9MM; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-7232-24
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device peeled off on the belly of the patient.The white sticky gauze came off the clear circular tape which had remained on the tegaderm dressing that remained on the belly.Event occurred while in use with the patient, there was no medical intervention required.
Additional Manufacturer Narrative
This file was originally incorrectly filed under registration number mrn (b)(4) the date of that submission was (b)(6)2024.Neither samples nor pictures were received for the analysis of this complaint.The device history record was reviewed, and it was confirmed that no non-conformities were reported during production.The quality inspection forms were reviewed, and no defects were found.The customer reported issue could not be confirmed.Without the return of the used samples a comprehensive failure investigation cannot be performed, and a probable cause cannot be determined.

• Brand Name: CLEO INSULIN SET, 9MM
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20048452
• Report Number: 3012307300-2024-07988
• Device Sequence Number: 18126082
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/22/2024

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: Health Professional
• 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: 06/13/2024
• Initial Report FDA Received Date: 08/23/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Unknown