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

Model Number	21-7040-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a leakage with the extension set when starting new drug load.The leakage appeared when the set was removed from the original packaging and it was connected to the cassette.No patient injury was reported.
Additional Manufacturer Narrative
Device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.The sample was received in used conditions without its original packaging.An occlusion was observed between the tube and filter.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 filter.The complaint is confirmed.Based on the tests results, it is concluded that the failure could be reproduce in two ways: when the excess of solvent is not cleaned before to assembly the tube with the component.When the tube is introduced two times in the solvent dispenser (procedure is not followed).The root cause could was determined to be linked with the manufacturing process.Alert was generated to ensure adherence to manufacturing procedure related to clean the excess of solvent before to assemble tube with the component.Personnel notification was performed 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): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; ofc 518; minneapolis, MN 55442
• MDR Report Key: 13341820
• Report Number: 3012307300-2022-01560
• Device Sequence Number: 17171657
• Product Code: FPA
• UDI-Device Identifier: 10610586020223
• UDI-Public: 10610586020223
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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
• Report Date (Section B): 01/25/2022

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
• Device Expiration Date: 11/19/2024
• Device Model Number: 21-7040-24
• Device Catalogue Number: 21-7040-24
• Device Lot Number: 3910168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2021
• Initial Report FDA Received Date: 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Hispanic