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

Model Number 21-7324-01

Device Problems Inaccurate Flow Rate (1249); Volume Accuracy Problem (1675); Inaccurate Delivery (2339)

Patient Problem Insufficient Information (4580)

Event Date 07/11/2021

Event Type  malfunction  

Event Description

Information was received regarding a cadd administration set.It was reported that during an epidural placement in the night, the residual volume did not correspond to what the two parturient women should have received.It is unknown is there was patient, or clinician injury associated with this occurrence.

Manufacturer Narrative

This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No problems or issues were identified during the device history record review.Two pictures were received for review.By the pictures received was unable to confirm the failure mode reported due the sample is needed in order to perform delivery accuracy test.No root cause was determined due to the complaint not being confirmed.

• Brand Name: CADD ADMINISTRATION SETS - FLOW STOP
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• 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: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12299217
• MDR Text Key: 265764693
• Report Number: 3012307300-2021-08244
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586029653
• UDI-Public: 10610586029653
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7324-01
• Device Catalogue Number: 21-7324-24
• Device Lot Number: 4071936
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female