MAUDE Adverse Event Report: ST PAUL CADD; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	21-7060-24
Medical Device Problem Codes	Obstruction of Flow (2423); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that while in use of a smiths medical cadd extension set, an occlusion was noted, and customer could not flow fluid in it.No patient consequences were reported.No adverse effects were reported.
Additional Manufacturer Narrative
H6: event problem and evaluation codes: updated after device evaluation.H10: device evaluation: the device was returned for investigation.A functional test was performed.Sample received: one (1) sample was received from p/n 21-7060-24 l/n 4148647; the sample received in used conditions with its original open packaging.Functional test: sample was tested using a syringe with colored water to detect any occlusion.Results: during the test, the water did not pass-through asv valve.The complaint is confirmed.Continuing with the analysis, it was tried to replicate the failure mode - conclusion: based on the tests results, it was concluded that the failure could be reproduced in two ways: 1.When the excess of solvent is not cleaned before assembly the tube with the component.2.When the tube is introduced two times in the solvent dispenser (procedure is not followed).The cause of the reported problem was traced to the manufacturing process.Personnel notification was performed on 08/feb/2022 to notify production personnel about the failure mode reported by the customer.

• Brand Name: CADD
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; akasaka, minato-ku, tokyo; minneapolis, MN 55442
• MDR Report Key: 13142484
• Report Number: 3012307300-2022-00009
• Device Sequence Number: 14638817
• Product Code: FPA
• UDI-Device Identifier: 10610586020438
• UDI-Public: 10610586020438
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K942046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2022

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 Expiration Date: 06/07/2026
• Device Model Number: 21-7060-24
• Device Catalogue Number: 21-7060-24
• Device Lot Number: 4148647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2021
• Supplement Date Received by Manufacturer: 03/01/2022
• Initial Report FDA Received Date: 01/03/2022
• Supplement Report FDA Received Date: 03/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2021
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown