MAUDE Adverse Event Report: SMITHS MEDICAL, ASD INC. CLEO; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 21-7230-24

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Injection Site Reaction (4562)

Event Date 04/20/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the patient experienced an injection site reaction.The reporter thought that the nodule was noticed upon removal of the cannula.The incident was not serve enough to the point where medical intervention was required.No further complications were reported in relation to this event.

• Brand Name: CLEO
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL, ASD INC.; 6000 nathan lane; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL, ASD INC.; 3350 granada avenue north; suite 100; oakdale MN 55128
• Manufacturer Contact: dave halverson ; 6000 nathan lane; minneapolis, MN 55442
• MDR Report Key: 10946890
• MDR Text Key: 219555790
• Report Number: 3012307300-2020-12080
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586028397
• UDI-Public: 10610586028397
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K042172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 21-7230-24
• Device Lot Number: 3900360
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1