MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CLEO® 90 INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-7222-24
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Unspecified Infection (1930); Foreign Body In Patient (2687)
Date of Event	03/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
Information was received indicating that four days prior the cannula to a smiths medical cleo® 90 infusion set broke off under the patient's skin.The patient reports seeking medical attention two times and has been prescribed antibiotics.Complaints of the site being reddened and scabbed over.Reported that if the cannula does not come out on its own, the patient will have to go to the emergency room to have it removed.No further adverse effects are reported.
Additional Manufacturer Narrative
5 pictures were received for evaluation.Per the photos, the cannula appeared broken.A review of the manufacturing process was performed in order to verify that there are no situations or practices that could cause or contribute to the field observation, no discrepancies were found.A functional test was performed on 3 samples from another lot number.The white cap of the sets were removed and the sites were inserted into an insertion pad.The inserted cannulas were twisted around and pulled from the insertion pad, none of these tests were able to reproduce the field observation as the cannula would not brake or detach.Based on the evidence, the complaint was unable to be confirmed.

• Brand Name: CLEO® 90 INFUSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7447375
• Report Number: 3012307300-2018-01237
• Device Sequence Number: 1768784
• Product Code: FPA
• UDI-Device Identifier: 30610586028353
• UDI-Public: 30610586028353
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K042172
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 21-7222-24
• Device Lot Number: 76X034
• 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: 04/02/2018
• Supplement Date Received by Manufacturer: 10/09/2018
• Initial Report FDA Received Date: 04/20/2018
• Supplement Report FDA Received Date: 11/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention