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

Model Number 21-7324-01

Device Problem Inaccurate Delivery (2339)

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

Event Date 05/29/2023

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 exhibited nothing or limited liquid was flowing through.Therefore, it had to be replaced at 2 weeks time.No adverse patient effects were reported by the customer.

Manufacturer Narrative

Other text: g1,2 email is: regulatory.Responses@icumed.Com.One device was returned for evaluation.Visual inspection revealed no physical damage.Functional testing was performed but the reported issue could not be replicated or confirmed; no discrepancies were detected.The root cause could not be determined.No further action was taken.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• Brand Name: CADD ADMINISTRATION SETS - 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: 17213322
• MDR Text Key: 318016602
• Report Number: 3012307300-2023-06754
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586029653
• UDI-Public: 10610586029653
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2023
• 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: 4334327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1