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

Model Number 21-7302-24

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354); Product Quality Problem (1506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/04/2023

Event Type  malfunction  

Event Description

It was reported when the disposable was disconnected from the pump.There was precipitate around the metal lock and the connection between the disposable and pump.No patient injury.

Manufacturer Narrative

A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Manufacturer Narrative

One device was returned for analysis.Visual inspection showed the device was without the blue clip, slide clamp and white cap.Due to no detection of contaminations, the reported issue was not duplicated.The cause of the reported issue was undetermined.A service history review identified there was no indication that the complaint was related to a service of the device within the review period.D3, g1, and g2 email is: (b)(6).

• Brand Name: CADD CASSETTE RESERVOIRS 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 16902938
• MDR Text Key: 314917263
• Report Number: 3012307300-2023-05471
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027239
• UDI-Public: 10610586027239
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2024

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
• Device Operator: Health Professional
• Device Model Number: 21-7302-24
• Device Catalogue Number: 21-7302-24
• Device Lot Number: 4203286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/05/2023
• Initial Date FDA Received: 05/10/2023
• Supplement Dates Manufacturer Received: 07/31/2023
• Supplement Dates FDA Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1