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

Catalog Number 21-7231-24

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/21/2017

Event Type  malfunction  

Manufacturer Narrative

Ten devices were returned for evaluation in unused condition. Visual inspection of the devices found no anomalies. Functional testing involved simulation testing and did not detect detachment or cannula removal issues. A review of the testing and inspection documents was performed and deemed adequate and correct. A review of the manufacturing process was performed on a similar part and found no discrepancies. Three devices from the manufacturing line were functionally tested and detected no detachment or cannula removal issues. Based on the evidence, a root cause was unable to be determined. No fault was found with the devices.

Manufacturer Narrative

Customer has not returned the device to the manufacturer for device evaluation. 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 while removing a cleo® 90 infusion set, the patient noticed most of the plastic cannula was no longer attached to the set. The patient believes the cannula is still in the skin at the infusion site. The infusion site was placed on the abdomen. No permanent injury was reported.

Manufacturer Narrative

The device is currently being evaluated; smiths medical will file a follow-up report detailing the results of the evaluation once it is completed. Device evaluation in progress.

• 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: 6572344
• MDR Text Key: 249798155
• Report Number: 3012307300-2017-01045
• 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,Followup,Followup
• Report Date: 12/20/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/15/2022
• Device Catalogue Number: 21-7231-24
• Device Lot Number: 77X017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 12/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial