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

Catalog Number 21-7220-24

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Burning Sensation (2146)

Event Date 02/01/2017

Event Type  Injury  

Manufacturer Narrative

Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun, as the device is currently in transit to the investigation site.

Event Description

It was reported that one day after placing a cleo® 90 infusion set, the patient experienced itching.Upon removing the catheter, the patient noticed there was a burn where the device had been on her abdomen.The patient went to the emergency room where she was prescribed fucidine and pyostacine.The patient also had an echography.The patient switched to a device from a different lot.No permanent injury was reported.

Manufacturer Narrative

Three samples of cleo® 90 infusion set were received in unused conditions with the cap seal closed.Samples were visually inspected at a distance of 12" to 24" under normal conditions of illumination.No damage could be detected on the unit.Sample was tested on the skin to see if there was a problem with the adhesive that could cause a problem on the patient's skin.No discrepancies were found.A review of the manufacturing and quality inspection processes were reviewed and considered adequate and correct.No root cause could be determined as the complaint was not confirmed.

• 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 MFG; s.a. de c.v. ave calidad no. 4; parque industrial internaciona; tijuana, 22425 ; MX 22425
• Manufacturer Contact: jennifer meng ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833078
• MDR Report Key: 6567584
• MDR Text Key: 75180278
• Report Number: 3012307300-2017-01030
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586028335
• UDI-Public: 10610586028335
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K042172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2017
• 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: 76X051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2017
• 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