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

Model Number	21-7040-24
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the device was returned for investigation in used conditions, without its original packaging.Leak test: sample was tested using a syringe with colored water.Results: during the test, leak was found between luer and tube, only one sample.The complaint is confirmed.The root cause could was determined to be linked to manufacturing process.Root cause is lack of solvent by not following the established procedure.Awareness notification was made to production personnel in order to explain the importance to adherence or following in the procedure (b)(4) "extension set with filter assembly" section 7.0 bond male luer to coil assembly, by quality engineer on (b)(6) 2021.
Event or Problem Description
It was reported the device displayed alarm -air in line-.While priming medicine, it does not make it through the extension set and generates high pressure alarm.Extension set was changed and infusion started correctly.No patient injury was reported.

• 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: 13341653
• Report Number: 3012307300-2022-01552
• Device Sequence Number: 3918794
• 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