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

Model Number	21-7105-24
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reporter provided a photograph for evaluation but the device was not shown (labeling only).No conclusion could be made based on the photograph provided.
Event or Problem Description
It was reported the device was being prepared and filled with drug.The reporter stated the drug "could not be released" from the cassette into the tubing.No patient involvement.

• Brand Name: CADD ADMINISTRATION SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10788651
• Report Number: 3012307300-2020-10987
• Device Sequence Number: 4141674
• Product Code: FPA
• UDI-Device Identifier: 10610586022715
• UDI-Public: 10610586022715
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K942046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/04/2020

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 Model Number: 21-7105-24
• Device Catalogue Number: 21-7105-24
• Device Lot Number: 3934893
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2020
• Initial Report FDA Received Date: 11/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1