MAUDE Adverse Event Report: ST PAUL CADD; ADMINISTRAION-FLOW STOP

Model Number	ADMINISTRATION-FLOW STOP
Medical Device Problem Codes	Break (1069); No Flow (2991)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/04/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Information received cadd administration sets - flow stop broken tubing at luer lock.Photos provided and no patient adverse events reported.
Additional Manufacturer Narrative
Device evaluation: one photo was provided as well as thirty (30) unused samples returned in unused condition in their original sealed packaging.The photo showed tubing that did not have the asv attached, the tube appeared too clear as it there was not enough solvent.This confirms the reported issue.Visual inspection of the samples showed the asv was joined to the tube and enough solvent was visible around the valve base.Functional testing involved pull testing.All samples passed the pull test successfully and the results were within specification.Based on the analysis all samples received were assembled properly and complied with the bonding specification; however, the picture confirmed the reported issue.One possible, but unconfirmed, problem source was listed as the operator not assembling the components correctly.

• Brand Name: CADD
• Common Device Name: ADMINISTRAION-FLOW STOP
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10133282
• Report Number: 3012307300-2020-05664
• Device Sequence Number: 11378088
• Product Code: FPA
• UDI-Device Identifier: 10610586027468
• UDI-Public: 10610586027468
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K031361
• 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
• Report Date (Section B): 04/29/2021

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: 02/15/2025
• Device Model Number: ADMINISTRATION-FLOW STOP
• Device Catalogue Number: 21-7381-24
• Device Lot Number: 3935900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/12/2020
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 06/09/2020
• Supplement Report FDA Received Date: 04/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 3 YR
• Patient Weight: 17