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

Catalog Number	21-7231-24
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#617147.No problem or issues were identified during the device history record review.Three pictures were attached for evaluation and nineteen samples were received decontaminated.During functional testing, any attempt to reprocess the device for subsequent re-use may adversely affect the integrity of the device or lead to deterioration in performance.No functional testing was made because the spring of the nineteen were activated.Production personnel performs 100 percent visual inspection using a black light in order to verify that drop has been placed at each joint and the amount of adhesive is correct.According with procedure, personnel verify the alignment and position of the adhesive with the cannula and that the central portion of the adhesive does not show any damage.Production personnel takes a sample of four (4) at start up, the beginning of every job and at least every (3) hours according with the procedure and performs the following test: insert site into insertion pad, tamper band separation, tegaderm adhesion to flange, needle retraction, site transfer and tubing pull test to male buckle and luer.According with the procedure, quality takes a sample size that to be determined daily based on the expected output and dividing the sample size so that a proportional amount is inspected at a 1 hourly interval with an accept or reject 1 criteria; in order to verify the following: tubes are bonded to the luer and buckle, bonds shall form a dome on top of the union point of the connector and tubing and that skin adhesive is fully and evenly adherence onto flange of retractor and that skin adhesive does not lift from the flange.Quality audits the adhesion testing of the skin adhesive and the pull testing of tubing set, at start up and at least every (3) hours, in order to verify that sample has met within specification.After sample evaluation, the complaint was not confirmed.Root cause is unknown.No corrective actions are required since the complaint was not confirmed.
Event or Problem Description
It was reported adhesive would not stay on patient's skin while in use.No patient injury 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: 16891189
• Report Number: 3012307300-2023-05345
• Device Sequence Number: 17677221
• Product Code: FPA
• UDI-Device Identifier: 10610586028403
• UDI-Public: 10610586028403
• 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: Foreign,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/08/2023

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 Expiration Date: 07/03/2025
• Device Catalogue Number: 21-7231-24
• Device Lot Number: 3984450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 05/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2020
• 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