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

Catalog Number 21-7231-24

Device Problem Detachment Of Device Component (1104)

Patient Problems Inflammation (1932); Device Embedded In Tissue or Plaque (3165)

Event Date 05/01/2017

Event Type  malfunction  

Manufacturer Narrative

It was reported on (b)(6) 2017 that the event occurred "in the past five weeks".The exact date is unknown.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 the cannula of a cleo® 90 infusion set detached from the site and remained in the patient's skin.The patient's right upper thigh was noted to have a "red thickening" due to inflammation from the cannula.No permanent injury was reported.

Manufacturer Narrative

Thirteen used cleo 90 infusion sets and one photo were received for investigation.The samples were visually inspected and it was revealed that eleven samples had detached cannulas and two samples had bent cannulas.The complaint was confirmed.A manufacturing review was performed and produced samples were tested and no detachment was detected in any of the tested samples and the cannula was not removed from the site.The root cause was determined to be a manufacturing error that caused the device to be improperly assembled.

• 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: 6753777
• MDR Text Key: 81388940
• Report Number: 3012307300-2017-01623
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586028403
• UDI-Public: 10610586028403
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/30/2022
• Device Catalogue Number: 21-7231-24
• Device Lot Number: 77X013
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1