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

Model Number	21-7395-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation in progress.
Event or Problem Description
It was reported that there was leakage from the filter of the cadd administration set.No patient injury or complications were reported in relation to this event.
Additional Manufacturer Narrative
Other, other text: device evaluation: two smiths medical cadd administration sets were returned for analysis in an unused condition with their original package.The samples were visually inspected under normal conditions of illumination and no discrepancies were found.Leak testing on the samples received were performed using hydrostat vessel to look for unusual functions; and a leak was observed fleeing from the air vent of the filter in the two samples.Based on the evidence, the complaint was confirmed, and the problem source of the reported event was noted to be manufacturing.
Additional Manufacturer Narrative
Additional information: h10: information was received on 12-jan-2021 indicating that there was patient involved in this event.The infusion was life sustaining (chemotherapy).It was also noted that the issue occurred one time and was resolved by replacing the device.

• Brand Name: CADD
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10328508
• Report Number: 3012307300-2020-07574
• Device Sequence Number: 3462729
• Product Code: FPA
• UDI-Device Identifier: 10610586027543
• UDI-Public: 10610586027543
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K040636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/10/2021

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 Expiration Date: 10/06/2022
• Device Model Number: 21-7395-24
• Device Catalogue Number: 21-7395-24
• Device Lot Number: 47X650
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/16/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/29/2020
• Supplement Date Received by Manufacturer: 10/01/2020; 01/12/2021
• Initial Report FDA Received Date: 07/27/2020
• Supplement Report FDA Received Date: 10/28/2020; 02/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1