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 03/14/2017

Event Type  Injury  

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.It was reported that patient could not recall the exact date and the date reported was approximate.

Event Description

It was reported that during patient use of the cleo® 90 infusion set, the cannula detached from the infusion site and the cannula remained partially inserted in the patient's body.The patient stated that she believed that the waistband of their pants may have sheared the infusion site from the patient's body.The patient reported that they were able to remove the device cannula without issue.According to the reporter, the patient's blood glucose level rose to approximately 300 mg/dl at the time of the event; the patient did not test their ketone levels.The patient administered an insulin injection via a syringe to resolve their high blood glucose.Additionally, the patient reported that they replaced their infusion site and resumed insulin delivery from the infusion pump.No issues were observed when the device was initially opened and the patient stated that they received iv dressings to aid in securing future infusion sites.No permanent adverse effects to patient 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: 6487556
• MDR Text Key: 72653563
• Report Number: 3012307300-2017-00837
• 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: 04/12/2017

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: 08/28/2021
• Device Catalogue Number: 21-7220-24
• Device Lot Number: 76X132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/22/2017
• Initial Date FDA Received: 04/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2016
• 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
• Patient Age: 57 YR
• Patient Weight: 79