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

Model Number 21-7221

Device Problems Detachment Of Device Component (1104); Device Operational Issue (2914)

Patient Problem Hyperglycemia (1905)

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 during application, adhesive stuck to the cap.Blood glucose level was impacted as a result and corrected by injection.No adverse health outcome resulted from this event.

Manufacturer Narrative

Five opened devices were returned for evaluation.Upon visual examination, the adhesive layer was found to be adhered to the inserter cap (instead of attached to the inserter/retractor as expected).The most likely causes of the reported issue were determined to be: the adhesive pad became detached; either during adhesive application or after white cap assembly or the adhesive pad was received defective from supplier which then allowed for the adhesive to become detached (after visual inspection).To address the two potential root causes identified, the manufacturing facility modified the assembly procedure to include an additional manufacturing step to ensure bonding between the adhesive pad and the inserter/retractor.The manufacturing facility also modified the 100% inspection of the adhesive pad; procedure was modified to include regular verification of alignment of the equipment.These changes were implemented in november 2015.To address the potential for defective adhesive pad, the manufacturing facility notified the adhesive pad supplier and requested an investigation.Supplier verified no issues were identified during manufacturing of the components listed.No further actions were identified by supplier.

• Brand Name: CLEO INFUSION 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: 5438222
• MDR Text Key: 38236538
• Report Number: 2183502-2016-00203
• 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: Patient
• Type of Report: Initial,Followup
• Report Date: 02/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/28/2020
• Device Model Number: 21-7221
• Device Catalogue Number: 21-7221-24
• Device Lot Number: 75X073
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2015
• 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