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

Catalog Number 21-7220-24

Device Problem Material Fragmentation (1261)

Patient Problems Hyperglycemia (1905); Device Embedded In Tissue or Plaque (3165)

Event Date 02/18/2017

Event Type  malfunction  

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 cannula of the cleo® 90 infusion set was "stuck" in the patient's leg and the cannula cannot be removed.The "stuck" cannula was observed after the patient successfully placed a new infusion site and it was noted that the old site remained in the patient's leg.The patient reported that their blood glucose level was 207 mg/dl at the time of the event.According to the report, the patient consulted their mother who is a registered nurse who stated that the site did not appear infected and that the patient should monitor the site.The patient stated that she will work on removing the cannula but will not seek medical attention until the patient "goes home for spring break".The patient also stated they do not need to seek medical attention unless the site becomes infected.The patient denied further follow-up regarding the issue.No patient injury was reported.

• 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, b.c 22425 ; MX 22425
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6419429
• MDR Text Key: 70415016
• Report Number: 3012307300-2017-00718
• 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: 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/28/2021
• Device Catalogue Number: 21-7220-24
• Device Lot Number: 76X114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2016
• 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 Age: 22 YR