MAUDE Adverse Event Report: ST PAUL CADD; ADMIN SET

Model Number	21-7036-01
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/02/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that tubing was leaking where cadd tubing fuses into the luer lock, connecting to the patient.No adverse effects occurred.
Additional Manufacturer Narrative
Device evaluation: one smiths medical cadd administration set was returned for analysis in a used condition and inside of a plastic bag without original packaging.Visual inspection was performed under normal conditions of illumination and no discrepancies were detected on the housing nor solvent bonds.During analysis, leak testing was performed using syringe to look for unusual functions.The sample was primed, and it was observed to keep flowing water through the entire tubing without any problems.Based on the evidence, the complaint was not confirmed, and the problem source of the reported event is unknown.

• Brand Name: CADD
• Common Device Name: ADMIN SET
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10137672
• Report Number: 3012307300-2020-05697
• Device Sequence Number: 2153387
• 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: user facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2020

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: 3926580
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/13/2020
• Supplement Date Received by Manufacturer: 10/01/2020
• Initial Report FDA Received Date: 06/10/2020
• Supplement Report FDA Received Date: 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1