MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD ADMINISTRATION SET WITH FLOW STOP; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	21-7345-24
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned.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 same incident occurred on two separate days where the device line was disconnecting from the white luer of the administration set.This incident occurred with two patients.No medical intervention was needed.No patient injury reported.
Additional Manufacturer Narrative
Other, other text: h10: a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample and three (3) pictures were received for evaluation.Visual inspection found a ring of solvent can be detected around the tube tip; failure mode reported is confirmed.Other analysis was not required.The root cause of the reported issue was found to be caused by incorrect solvent dispense set up (insufficient solvent in solvent pot).Production personnel was notified by quality engineer on 31-jan-2023 as awareness for the failure mode reported by costumer.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: CADD ADMINISTRATION SET WITH FLOW STOP
• 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: 15361779
• Report Number: 3012307300-2022-17867
• Device Sequence Number: 6049597
• Product Code: FPA
• UDI-Device Identifier: 15019517191714
• UDI-Public: 15019517191714
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K031361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2023

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: Health Professional
• Device Expiration Date: 12/08/2025
• Device Model Number: 21-7345-24
• Device Catalogue Number: 21-7345-24
• Device Lot Number: 4084035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2022
• Supplement Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 09/06/2022
• Supplement Report FDA Received Date: 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/28/2020
• 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