MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. INF SET CLEO 24" 9MM; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 21-7230-24

Device Problems Disconnection (1171); Insufficient Flow or Under Infusion (2182); Air/Gas in Device (4062)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2024

Event Type  malfunction  

Event Description

It was reported that during use, the tubing came apart; the flexible tubing had disconnected from the hard plastic connector.There were several air bubbles as the patient had jammed the tubing back together and the patient was instructed not to use that device.It was unknown how long the patient was without therapy.The patient presented to the emergency room for medication restart.The device system delivered remodulin.

Manufacturer Narrative

Event date unknown.Device not received by manufacturer.No product was returned.The reported complaint could not be confirmed.If the product is returned this complaint will be reopened for further investigation.No lot number was provided; therefore, a history record review could not be conducted.

• Brand Name: INF SET CLEO 24" 9MM
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18908954
• MDR Text Key: 337733214
• Report Number: 3012307300-2024-01396
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 30610586028391
• UDI-Public: 30610586028391
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 21-7230-24
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: REMODULIN
• Patient Age: 54 YR
• Patient Sex: Male