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

Catalog Number 21-7231-24

Device Problems Fluid Leak (1250); Material Fragmentation (1261)

Patient Problems Skin Irritation (2076); Chemical Exposure (2570); Device Embedded In Tissue or Plaque (3165)

Event Date 05/02/2017

Event Type  malfunction  

Manufacturer Narrative

Three 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

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.

Event Description

It was reported that the plastic cannula of a cleo® 90 infusion set broke off inside the patient's abdomen during infusion set removal. The fault was noticed by the patient's wife and home care nurse. The site had been cleaned with chlorhexidine prior to insertion. The set had been in use for 24 hours at the time of the event. As a result of the event, apomorphine flowed back out of the cannula and onto the patient's skin, which caused small wounds around the infusion set site. It was observed that the wounds looked "calm" and were healing. The patient consulted with a medical specialist regarding the event. The medical specialist decided not to remove the cannula, and to let the cannula "outgrow" itself. No permanent injury was reported. See mfr: 3012307300-2017-01121 and 3012307300-2017-01124.

• 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: 6591673
• MDR Text Key: 106209161
• Report Number: 3012307300-2017-01123
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K042172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/20/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/08/2022
• Device Catalogue Number: 21-7231-24
• Device Lot Number: 77X005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2017
• 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: 02/20/2022
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial