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

Catalog Number	21-7222-24
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reporting that during placement of a cleo® 90 infusion set, the needle didn't retract into the inserter, instead it remained stuck in the cannula.No injury was reported.
Additional Manufacturer Narrative
One device was returned for evaluation in used condition and without its original packaging.Visual inspection of the device found the retractor was activated, the cap seal was open, and the needle remained in the inserter.Functional testing was unable to be performed as the unit had been activated.A review of the testing and inspection documents was performed and deemed adequate and correct.A review of the manufacturing process was performed on a similar part and found no discrepancies.A sample of 32 devices from the production floor were visually inspected and found no discrepancies.Based on the evidence, the root cause was attributed to a manufacturing issue; the most probable root cause was related to the production personnel not detecting the missing solvent in the needle.

• 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: 6898043
• Report Number: 3012307300-2017-02078
• Device Sequence Number: 636859
• Product Code: FPA
• UDI-Device Identifier: 10610586028359
• UDI-Public: 10610586028359
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K042172
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2018

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: No Information
• Device Expiration Date: 11/17/2021
• Device Catalogue Number: 21-7222-24
• Device Lot Number: 76X188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2017
• Supplement Date Received by Manufacturer: 03/02/2018
• Initial Report FDA Received Date: 09/27/2017
• Supplement Report FDA Received Date: 03/16/2018
• 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