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

Model Number	21-7036-01
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/17/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was in use and the device leaked near the air filter.No adverse effects to patient reported.

• 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: 10603234
• Report Number: 3012307300-2020-09960
• Device Sequence Number: 14436651
• Product Code: FPA
• UDI-Device Identifier: 10610586020186
• UDI-Public: 10610586020186
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K933390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/29/2020

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: No Information
• Device Model Number: 21-7036-01
• Device Catalogue Number: 21-7036-01
• Device Lot Number: UNKNOWN
• 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: 09/09/2020
• Initial Report FDA Received Date: 09/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1