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

Catalog Number 21-7220-24

Device Problem Bent (1059)

Patient Problem Hyperglycemia (1905)

Event Date 09/14/2017

Event Type  Injury  

Event Description

It was reported that a cannula to a smiths medical cleo® 90 infusion set was bent leading to the patient's blood sugar reading of 290.The patient changed out the site and an insulin bolus was required.The patient recovered with no further adverse effects.

• 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 MANUFACTURING; s.a. de c.v.; a d no.4 parque industrial int; tijuana, b.c. 22425 ; MX 22425
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7638383310
• MDR Report Key: 6917849
• MDR Text Key: 88367827
• Report Number: 3012307300-2017-02158
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586028335
• UDI-Public: 10610586028335
• 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: Other
• Type of Report: Initial
• Report Date: 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/17/2022
• Device Catalogue Number: 21-7220-24
• Device Lot Number: 77X019
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 15 YR