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

Catalog Number	21-7230-24
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: a supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported the disposable leaked during administration to the patient.Site personnel confirmed proper placement of the infusion set.Wet spots were observed on the patient's clothing at the end of the infusion.No adverse patient effects were reported by the customer".
Additional Manufacturer Narrative
Forty samples were received for evaluation.The samples were received in unused condition.Of the 40 samples, 8 were selected; 2 were randomly selected from each box.Visual inspection revealed the samples were with their original packaging and decontaminated inside its unitary box.No detected any defect visual in the set infusion for the 8 samples.Functional testing was performed but the reported issue could not be replicated.No root cause could be determined as no device problem was found.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No actions were taken.Email address: (b)(6).

• Brand Name: CADD CLEO 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): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17010445
• Report Number: 3012307300-2023-05733
• Device Sequence Number: 17874628
• Product Code: FPA
• UDI-Device Identifier: 10610586028397
• UDI-Public: 10610586028397
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K042172
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2024

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 Expiration Date: 12/11/2025
• Device Catalogue Number: 21-7230-24
• Device Lot Number: 4082953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2023
• Supplement Date Received by Manufacturer: 07/07/2023
• Initial Report FDA Received Date: 05/26/2023
• Supplement Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown