MAUDE Adverse Event Report: ST PAUL CLEO; INTRAVASCULAR ADMINISTRATION SET

Model Number 21-7221-24

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hypoglycemia (1912)

Event Date 06/01/2020

Event Type  malfunction  

Event Description

Information was received that there was fluid leakage observed from the junction site.The leakage reportedly resulted in hyperglycemia for the patient.No further injuries were reported.

• Brand Name: CLEO
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 10686453
• MDR Text Key: 211566463
• Report Number: 3012307300-2020-10354
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 30610586028346
• UDI-Public: 30610586028346
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K042172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 21-7221-24
• Device Catalogue Number: 21-7221-24
• Device Lot Number: 3919757
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1