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

Model Number 21-7302-24

Device Problems Filling Problem (1233); Fluid/Blood Leak (1250); Insufficient Flow or Under Infusion (2182)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Information was received regarding a cadd cassette reservoir.It was reported that once the pouch has been filled with 100ml of solution, one can see the liquid go into the empty space between the pouch and the case.By tilting the pouch, it comes out through the openings in the case.This occurred during the patient's sleep hours.Over the course of the week, the customer found the problem in 6 of the 12 pouches used.There was no patient, or clinician injury associated with this occurrence.

Manufacturer Narrative

Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No problem or issues were identified during the device history record review.Twenty-six units were received for evaluation.Twenty-one of the samples were returned with its original packaging closed and five were returned decontaminated without their original packaging.During visual inspection, the samples were visually inspected under normal conditions of illumination.The sample units did not present any damage, scuffs, pinch marks, cracks, crazing, cuts, etc.Could cause the failure mode reported.During functional testing, leak testing was performed on the units that were received unopened (21 units) according to the procedure to detect leaks in the product.The sample units passed the leak test.Also, the twenty-six sample units were filled with colored water using a syringe in order to detect any leakage.The twenty-six sample units did not present leaks.Therefore, complaint is not confirmed.No root cause could be determined since the complaint was not confirmed and no actions were taken.

• Brand Name: CADD ADMINISTRATION SET WITH FLOW STOP
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; strada rivalta 46; minneapolis, MN 55442
• MDR Report Key: 12012703
• MDR Text Key: 256717493
• Report Number: 3012307300-2021-06140
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027239
• UDI-Public: 10610586027239
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 21-7302-24
• Device Catalogue Number: 21-7302-24
• Device Lot Number: 4037756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1