MAUDE Adverse Event Report: ST PAUL CADD ADMINISTRATION SETS - FLOW STOP; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	21-7391-24
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This remediation mdr was generated under protocol b10010116, as a result of warning letter cms# (b)(4).No problems or issues were identified during this device history record review.One sample was received in a used condition without their original packaging and inside in a plastic bag.Visual and functional testing were performed.Visual inspection was performed at 12 to 16 inches under normal conditions of illumination to detect sample conditions that could cause functional issues.No damages nor workmanship defects were detected on the sample.During the functional testing, a leak was detected in the bond with the pump tube, thus the failure mode reported was confirmed.The root cause was lack/insufficient cyclohexanone adhesive was defined per the variables that have process for the solvent application to the tube coiled.The retrospective review on this failure reported shown that there was no increase on this failure reported, therefore the current mitigation implemented will be revisited their adherence to confirm effectiveness and no disruptions in the execution that could cause the presence of this condition in the device.
Event or Problem Description
It was reported while providing teaching on pump with tubing was trying to display clamp alarm so tubing was clamped and the infusion liquid leaked out the side of the cassette and no clamp alarm displayed or ever alarmed as infusion continued.Occurred during priming and infusion.No patient injury was reported.

• Brand Name: CADD ADMINISTRATION SETS - FLOW STOP
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16876165
• Report Number: 3012307300-2023-05147
• Device Sequence Number: 5830516
• Product Code: FPA
• UDI-Device Identifier: 10610586027512
• UDI-Public: 10610586027512
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K040636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/05/2023

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: 21-7391-24
• Device Catalogue Number: 21-7391-24
• Device Lot Number: 4207862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2023
• Initial Report FDA Received Date: 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown