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

Model Number 21-7322-24

Device Problems Failure to Deliver (2338); Inaccurate Delivery (2339)

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

Event Date 11/25/2022

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.The customer provided the following as potential lot numbers 4321321 and 4227760.

Event Description

It was reported that the pump did not complete the infusion, the bag was still full.

Manufacturer Narrative

Evaluation codes: updated.Device evaluation: no product was returned.No photographic or diagnostic evidence was provided by the customer.The product's history records were reviewed and there were no non-conformance's nor service-related issues that would have resulted in the reported complaint.If the device is later returned, the complaint will be reopened and an investigation will be completed.

• Brand Name: CADD ADMINISTRATION SETS WITH FLOW STOP
• Type of Device: SET ADMINISTRATION
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16611504
• MDR Text Key: 312072714
• Report Number: 3012307300-2023-03007
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586029646
• UDI-Public: 10610586029646
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/19/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: 21-7322-24
• Device Catalogue Number: 21-7322-24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/04/2023
• Initial Date FDA Received: 03/24/2023
• Supplement Dates Manufacturer Received: 09/21/2023
• Supplement Dates FDA Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Male