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

Model Number 21-7302-24

Device Problem Fluid/Blood Leak (1250)

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

Event Date 09/01/2021

Event Type  malfunction  

Event Description

Information was received regarding a cadd cassette reservoir.It was reported that during the use of the product, leakage of medical fluid within the cassette was observed.There was no patient, or clinician injury associated with this occurrence.No further details provided at this time.

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.One sample was received without the original opened packaging, decontaminated a connected to an extension set, without blue clip, without white cap and inside in a plastic bag.During the functional testing, a leak was detected, the sample unit presented a leak in the join with the tube of the bag, therefore the complaint was confirmed.The root cause was due to manufacturing equipment failure and the procedure not being followed.A corrective and preventative action has been opened to address the reported issue.

• Brand Name: CADD CASSETTE RESERVOIRS - 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; 7-15-26 fukushima,; minneapolis, MN 55442
• MDR Report Key: 12698566
• MDR Text Key: 278390981
• Report Number: 3012307300-2021-10251
• 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,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/02/2023

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: Health Professional
• Device Model Number: 21-7302-24
• Device Catalogue Number: 21-7302-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/28/2021
• Initial Date FDA Received: 10/26/2021
• Supplement Dates Manufacturer Received: 09/28/2021
• Supplement Dates FDA Received: 05/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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