MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC CLEO® 90 INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 21-7220-24

Device Problems Bent (1059); Kinked (1339)

Patient Problem Hyperglycemia (1905)

Event Date 11/28/2016

Event Type  Injury  

Manufacturer Narrative

Customer has not yet returned the device to the manufacturer for device evaluation. When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.

Event Description

It was reported that the cleo® 90 infusion sets were bent and kinked. The patient stated that his blood glucose rose to over the 500'smg/dl due to him running out of supplies. Thus; he switched to manual daily injections to manage his blood glucose levels. He also contacted his distributor regarding the infusion set issue. The distributor put in a new order for more supplies to be delivered to him. No permanent adverse effects to patient reported. See mfr # 3012307300-2017-00047, 3012307300-2017-00048, 3012307300-2017-00050, 3012307300-2017-00051, 3012307300-2017-00052.

• Brand Name: CLEO® 90 INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS HEALTHCARE MFG; s.a. de c.v. ave calidad no. 4; parque industrial; internacional, tijuana,, B.C. 2242; MX B.C. 22425
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6238317
• MDR Text Key: 64422570
• Report Number: 3012307300-2017-00049
• Device Sequence Number: 1
• Product Code: FPA
• 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: consumer,distributor

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/28/2021
• Device Catalogue Number: 21-7220-24
• Device Lot Number: 76X121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 01/10/2017 Patient Sequence Number: 1