MAUDE Adverse Event Report: SMITHS HEALTHCARE MFG CLEO® 90 INFUSION SET; SUBCUTANEOUS INFUSION SET

Catalog Number 21-7231-24

Device Problems Sticking (1597); Component Missing (2306); Packaging Problem (3007)

Patient Problem Hyperglycemia (1905)

Event Date 06/09/2016

Event Type  Injury  

Manufacturer Narrative

Additional 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.Lot number 75x172 also provided, but since no specifics were included as to what device issue applied to which lot.

Event Description

Device distributor reported on behalf of the home care user that the patient had several defective cleo's.When the package was open, it was stated that "most" of them had the adhesive patch stuck on the lid and "some" of them had the adhesive patch completely missing.(specifics on which/how many per lot was not provided).The patient's blood glucose rose to 300 mg/dl and he required multiple daily injections.Trace ketones were noted.No injury was reported.Refer to mfr # 2183502-2016-01432, 2183502-2016-01433, 2183502-2016-01434, 2183502-2016-01435, 2183502-2016-01436, 2183502-2016-01437, 2183502-2016-01438, 2183502-2016-01439, 2183502-2016-01440, 2183502-2016-01442, 2183502-2016-01443, 2183502-2016-01444, 2183502-2016-01445, 2183502-2016-01446, 2183502-2016-01447, 2183502-2016-01448, 2183502-2016-01449, 2183502-2016-01450, 2183502-2016-01451, 2183502-2016-01452, 2183502-2016-01453, 2183502-2016-01454, 2183502-2016-01455, 2183502-2016-01456, 2183502-2016-01457, 2183502-2016-01459, 2183502-2016-01460, 2183502-2016-01461.

• Brand Name: CLEO® 90 INFUSION SET
• Type of Device: SUBCUTANEOUS INFUSION SET
• Manufacturer (Section D): SMITHS HEALTHCARE MFG; s.a.dec.v. ave, calidad no. 4; parque industrial internaciona; tijuana, bc 22425 ; MX 22425
• Manufacturer (Section G): SMITHS HEALTHCARE MFG; s.a.dec.v. ave, calidad no. 4; parque industrial internaciona; tijuana, bc 22425 ; MX 22425
• Manufacturer Contact: lisa perz ; 1265 grey fox road; st paul 55112 ; 7633833074
• MDR Report Key: 5788300
• MDR Text Key: 49362274
• Report Number: 2183502-2016-01441
• 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: 06/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/28/2020
• Device Catalogue Number: 21-7231-24
• Device Lot Number: 75X178
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 14 YR