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

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Type  Injury  

Manufacturer Narrative

Date of event: the patient reported "about a year ago".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 had broken off and detached inside the patient's body under his skin.The site was located at either the patient's buttock or the inner thigh of the patient's left leg.The patient's blood sugar levels rose as high as 400mg/dl due to the event; the blood sugars were typically kept at 110mg/dl.The patient noted that he was very active and very lean and wore loose fitting jeans that do not tug on the device.The infusion set was either replaced with a new set or an injection was used to bring down the blood sugar levels.No permanent injury was reported.See mfr: 3012307300-2016-00545 and 3012307300-2016-00546.

Manufacturer Narrative

One used cleo® 90 infusion set was returned for investigation.Visual inspection revealed of the returned site found that the soft cannula had separated approximately 2mm from the base; the remaining length of cannula was not returned.Upon further examination, no other defects were found with the device; the wall thickness of the cannula and the site crown appeared as intended.Investigation was unable to determine the root cause of the cannula separation; however, no evidence was found to suggest an intrinsic defect in the site.

Manufacturer Narrative

Please note: the patient reported that they weigh between (b)(6).The patient reported that the events have occurred over the "last 2 years" and the exact event dates are unknown.Age/date of birth, weight, date of event, describe event or problem - additional information.

Event Description

Additional information was received regarding the reported incident.The patient reported the cannula of the cleo 90 infusion set detached from the site and remained in the patient skin.The patient reported that they attempted to remove the cannula from their body; however, they were unable to.The patient stated that they spoke to their endocrinologist regarding the reported incident.It was reported that the patient did not receive any additional medical treatment due to the reported event.According to the patient the incident was unresolved.

• 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: 6167362
• MDR Text Key: 62185151
• Report Number: 3012307300-2016-00543
• 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
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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