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

Catalog Number 21-7220-24

Device Problems Sticking (1597); Component Missing (2306); Separation Failure (2547)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Manufacturer Narrative

It was reported on (b)(6) 2017 that the event happened "within the last 10-15 days".The exact date is unknown.Customer has not returned the device to the manufacturer for device evaluation.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 adhesive of a cleo® 90 infusion set was stuck to the cap.The patient's blood glucose levels were over 300mg/dl at the time of the event.Patient administered an insulin injection in order to address the high blood glucose levels.No permanent injury was reported.See mfr: 3012307300-2017-01035, 3012307300-2017-01037, 3012307300-2017-01038, and 3012307300-2017-01039.

Manufacturer Narrative

Smiths medical received three cleo® 90 infusion set without original packaging for analysis (one was received in used condition, one in unused condition, one white cap with adhesive stuck in the top).Upon visual examination two samples with the adhesive stuck in the white cap and one did not have the adhesive noted.Relevant documents and operations were reviewed and deemed adequate.Production floor inventory review was conducted on (b)(4) units in order to inspect the skin adhesive with no discrepancies were detected.Based on the evidence the complaint was confirmed.However, the root cause is unknown.Smiths medical received three cleo® 90 infusion set for analysis.However, it is not known as to which set is related to which report.Two reportable complaints (3012307300-2012-01039-240991, 3012307300-2012-01040-240992) and one non-reportable ((b)(4)).

• 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 internaciona; tijuana, 22425 ; MX 22425
• Manufacturer Contact: jennifer meng ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833078
• MDR Report Key: 6570506
• MDR Text Key: 75278000
• Report Number: 3012307300-2012-01040
• 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
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/18/2021
• Device Catalogue Number: 21-7220-24
• Device Lot Number: 76X168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/21/2017
• Initial Date FDA Received: 05/16/2017
• Supplement Dates Manufacturer Received: 01/08/2018
• Supplement Dates FDA Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2016
• 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