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

Model Number	21-7232-24
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.No information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.
Event or Problem Description
It was reported that when flushing the port prior to medication administration, fluid was noted to be under the dressing.The dressing was removed for inspection and multiple pieces of plastic fell out from under the dressing along with the saline.The knob that the needle inserts in had broken off from the base with the cannula still attached to it.Half of the octagon shaped enclosure had also broken away from the base.No patient injury was reported.

• 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
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15361059
• Report Number: 3012307300-2022-17839
• Device Sequence Number: 14953277
• Product Code: FPA
• UDI-Device Identifier: 30610586028414
• UDI-Public: 30610586028414
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K042172
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/06/2022

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
• Device Expiration Date: 12/12/2024
• Device Model Number: 21-7232-24
• Device Catalogue Number: 21-7232-24
• Device Lot Number: 3910208
• 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: 04/22/2022
• Initial Report FDA Received Date: 09/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2020
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown