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

Model Number 21-7302-24

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2021

Event Type  malfunction  

Event Description

Information was received indicating that the cadd cassette reservoirs - flow stop leaked during use with a patient.There were no adverse events reported.

Manufacturer Narrative

Other, other text: additional information: d10, h6, h10: three pictures of smiths medical cadd cassette reservoir were received.In pictures, no damage could be detected in the sample.Device evaluation: one smiths medical cadd cassette reservoir was returned for analysis in a used condition.Leak testing on the sample received was performed using a syringe to look for unusual functions.The sample was filled without issues; no leaks were found during the test.The complaint is not confirmed.Based on the evidence, the complaint was not confirmed, and no fault was found.

Manufacturer Narrative

Other text: additional information after investigation of device a functional test was performed on device, the sample presented a leak in the joint of the tube of the bag.The reported problem was confirmed.The root cause of the reported issue was found to be manufacturing equipment failure of bag sealer machine, and as a procedural failure where process was not followed as is required, forcing the equipment to release parts with potential leak condition.Corrective and preventive action (capa) was initiated and the results of capa were implemented by the concerned department to resolve the reported problem.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: CADD
• 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: david halverson ; 6000 nathan lane north; 3-10-15, hakata station east,; minneapolis, MN 55442
• MDR Report Key: 11405841
• MDR Text Key: 234487996
• Report Number: 3012307300-2021-01697
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027239
• UDI-Public: 10610586027239
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 21-7302-24
• Device Lot Number: 4037753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/12/2022
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1