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

Model Number 21-7002-24

Device Problem Leak/Splash (1354)

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

Event Date 03/29/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported the disposable was leaking.Patient not affected.No patient injury.No additional information available.

Manufacturer Narrative

One device was returned for analysis.Visual inspection showed the device was in good condition.A functional test was performed to test for leakage and the reported issue was not duplicated.No root cause was determined as reported issue was due not confirmed.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 - NON 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: 16761177
• MDR Text Key: 313498097
• Report Number: 3012307300-2023-04240
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10610586022128
• UDI-Public: 10610586022128
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K843772
• 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: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7002-24
• Device Catalogue Number: 21-7002-24
• Device Lot Number: 4271467
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/10/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1