MAUDE Adverse Event Report: SMITHS MEDICAL, ASD, INC. CLEO® 90 INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 21-7230-24

Device Problem Break (1069)

Patient Problem Local Reaction (2035)

Event Date 01/25/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the cannula of a cleo® 90 infusion set remained under the skin of the patient during the removal of the set.The skin of the patient observed: redness and induration.A surgical procedure took place for the removal of the cannula.No other adverse health outcomes were reported.

Manufacturer Narrative

Three cleo® 90 infusion sets were returned from the same part number as the product in question for analysis in unused conditions.The samples were visually inspected at a distance of 12" to 24" and normal conditions of illumination.No discrepancies were found.The samples in unused condition were tested by inserting into an insertion pad.No detachments were detected in any of the samples.The manufacturing and quality inspection processes were reviewed and considered adequate and correct.The product fault was not confirmed.See mfr: 3012307300-2018-00732.

• 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 MANUFACTURING S.A. DE C.V.; avenida calidad no. 4; parque industrial internaciona; tijuana, baja california 22425 ; MX 22425
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7355237
• MDR Text Key: 102963821
• Report Number: 3012307300-2018-00703
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586028397
• UDI-Public: 10610586028397
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/27/2018

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 Catalogue Number: 21-7230-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/23/2018
• Initial Date FDA Received: 03/20/2018
• Supplement Dates Manufacturer Received: 06/29/2018
• Supplement Dates FDA Received: 07/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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