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

Catalog Number	21-7232-24
Medical Device Problem Codes	Leak/Splash (1354); Connection Problem (2900); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.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 that the device's overlay adhesive was not adhering to the subject.Adherence to the device is stronger than adherence to subject causing lifting and removal of the catheter after insertion.The catheter was damaged and leakage was also reported.No patient injury was reported.
Additional Manufacturer Narrative
Device evaluation: inspection was made based on the pictures provided by the customer; samples returned were from unused device and analysis will be performed when samples are returned to determine if those have the condition reported.Visual inspection was performed, however investigator was unable to confirm the complaint reported, pictures provided does not allow to determine the area that is reported with the issue.Historical data from last 12 months were reviewed and no complaints with the same failure mode were confirmed.Based on the picture provided it was not possible to identify the specific area where the adhesion issues are thus the root cause was not confirmed.Based on the device history record review and from process inspection controls, (b)(4) parts were tested with no issues reported.No corrective actions were required since root cause can not be determined.The likelihood of this condition being observed is low and could be caused by incorrect manipulation of the adhesive.Device history review summary: the lot was manufactured with (b)(4) units, lot met the requirements to release the lot with no deviations identified during their manufacture.

• 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; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15329915
• Report Number: 3012307300-2022-17104
• Device Sequence Number: 14787153
• Product Code: FPA
• UDI-Device Identifier: 10610586028410
• UDI-Public: 10610586028410
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2022

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
• Operator of Device: Health Professional
• Device Catalogue Number: 21-7232-24
• Device Lot Number: 4230881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2022
• Supplement Date Received by Manufacturer: 09/08/2022
• Initial Report FDA Received Date: 08/31/2022
• Supplement Report FDA Received Date: 09/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2022
• 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