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

Model Number 21-7231

Device Problems Detachment Of Device Component (1104); Fracture (1260)

Patient Problems Foreign Body In Patient (2687); No Information (3190)

Event Date 01/05/2016

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.

Event Description

Distributor reported on behalf of user facility that 1mm of the device "needle" detached during use and remained in the body of the patient.It is unknown if the "needle" component is referring to the small metal inserter needle or the plastic cannula on the administration set.This information has been requested from the reporter.The 1mm device fragment was removed from the patient through a small incision.Two stitches were required to close the incision.No further adverse effects to patient were reported.

Manufacturer Narrative

One used infusion site was returned for evaluation.The examination of the infusion site showed that the cannula had broken off at approximately 1mm where it was attached to the base of the site.Examination under microscopy showed that the cannula was slightly bent over on one side.The remaining length of cannula was not returned.The examination under microscopy showed no abnormalities in the cannula wall thickness.The investigation could not establish root cause, but did not find any evidence to show the issue was caused by an intrinsic defect in the product.

• Brand Name: CLEO INSULIN SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD INC.; 1265 grey fox road; st. paul MN 55112
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: michele seliga ; 1265 grey fox rd.; st. paul, MN 55112 ; 7633833052
• MDR Report Key: 5419259
• MDR Text Key: 37776547
• Report Number: 2183502-2016-00152
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K042172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/09/2016

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/28/2020
• Device Model Number: 21-7231
• Device Catalogue Number: 21-7231-24
• Device Lot Number: 75X100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/15/2016
• Initial Date FDA Received: 02/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2015
• 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): Hospitalization; Other