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

Model Number	21-7345-24
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the line disconnected from the white luer of the admin set.No patient injury was reported.
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.
Additional Manufacturer Narrative
B5: additional information received via email from customer on 12-sep-2022 and attached in complaint object: "product normally used' and 'product tracking'.They normally purchase and use the set but have been using the set lines as an alternative.Additional information received via email from customer on 20-sep-2022: product and paperwork returned: event date updated per customer report to 25-aug-2022, then updated on 29-aug-2022.H10: device evaluation 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.
Additional Manufacturer Narrative
H10: device evaluation: three picture samples were attached for evaluation.The complaint returned unit was visually inspected under normal conditions of illumination to detect conditions that could cause functional issues.The product was received and was easily removed from the tube, not enough marks of solvent could be detected around the tube tip; failure mode reported was confirmed.Per the investigation, the bond was bad (weld connection issue).Based on the analysis conducted with the sample received, the failure was reproduced, therefore in accordance with procedure the occurrence for this failure condition could be caused by incorrect solvent dispense set up (insufficient solvent in solvent pot).For corrective action, production personnel were notified by quality engineer, as awareness for the failure mode reported by costumer.The root cause was traced to the manufacturing process.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: CADD ADMINISTRATION 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: 15351322
• Report Number: 3012307300-2022-17553
• Device Sequence Number: 17641782
• 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,Followup
• 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: 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: 09/20/2022; 04/07/2023
• Initial Report FDA Received Date: 09/02/2022
• Supplement Report FDA Received Date: 10/06/2022; 05/10/2023
• 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