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

Catalog Number	21-7232-24
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This remediation mdr was generated under protocol b10010116, as a result of warning letter cms# (b)(4).No problems or issues were identified during this device history record review.A product sample was received for evaluation.Visual and functional testing were performed.The needle was observed detached and adhered to the adhesive.The root cause of the reported issue was found to be lack of solvent by not followed to procedure.Actions were taken to mitigate the reported issue: awareness notification was made to production personnel in order to explain the importance to adherence or following in the procedure.
Event or Problem Description
It was reported that the needle did not retract into the punch, instead it got stuck twisted in the users skin and was difficult to remove.No patient injury was reported.

• Brand Name: CADD CLEO INFUSION SETS
• 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: 16901969
• Report Number: 3012307300-2023-05460
• Device Sequence Number: 5371518
• Product Code: FPA
• UDI-Device Identifier: 10610586028410
• UDI-Public: 10610586028410
• 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
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/10/2023

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: Lay User/Patient
• Device Catalogue Number: 21-7232-24
• Device Lot Number: 3919795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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