MAUDE Adverse Event Report: SMITHS HEALTHCARE MFG CLEO® 90 INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 21-7220-24

Device Problems Material Fragmentation (1261); Device Or Device Fragments Location Unknown (2590)

Patient Problems Erythema (1840); Device Embedded In Tissue or Plaque (3165)

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.

Event Description

It was reported that the cleo inner cannula broke off and stayed in the patient's skin.When the cannula was pulled out of the fatty part of the patient's back, he noticed it was not the full length and something was missing.Redness was noted, but the patient had no pain.The patient had not sought any medical treatment.No permanent impairment was reported.See mfr # 2183502-2016-01497.

• Brand Name: CLEO® 90 INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 5799852
• MDR Text Key: 49735420
• Report Number: 2183502-2016-01498
• 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
• Report Date: 06/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/28/2021
• Device Catalogue Number: 21-7220-24
• Device Lot Number: 76X049
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2016
• 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): Other