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

Catalog Number 21-7220-24

Device Problem Break (1069)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

The patient reported the device issue occurred on (b)(6) 2016 and reported that there were blood glucose issues since approximately (b)(6) 2016.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.(b)(4).

Event Description

It was reported that a cleo® 90 infusion set cannula broke off in the patient's body under her skin.The patient's healthcare professional did not remove the cannula and recommended to monitor site.The patient did not know if her blood glucose levels were affected by the reported issue as the patient was experiencing low and high blood glucose levels prior to event.It was noted that the patient experienced high blood glucose levels in the high 200s and low 300s (mg/dl), low blood glucose levels in the 60s (mg/dl), and lowest of 44mg/dl since approximately (b)(6) 2016.The high and low blood glucose was addressed by delivering a pump bolus and consuming carbohydrates, respectively.No permanent 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: 6113147
• MDR Text Key: 60356470
• Report Number: 3012307300-2016-00335
• 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: Other
• Type of Report: Initial
• Report Date: 10/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/28/2021
• Device Catalogue Number: 21-7220-24
• Device Lot Number: 76X108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention