MAUDE Adverse Event Report: ST PAUL CADD CLEO INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 21-7230-24

Device Problem Material Fragmentation (1261)

Patient Problems Inflammation (1932); Skin Discoloration (2074); Device Embedded In Tissue or Plaque (3165)

Event Date 04/02/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that a patient using the cleo device experienced a foreign body; needle retained in the abdomen.The patient's blood sugar levels were 11 mmol/l.The event occurred on (b)(6) 2019.Medical attention was sought, and the patient received an ultrasound and ct scan.The test results were inconclusive despite the physician feeling confident that a portion of the cannula had broken off under the patient's skin.The unbroken portions of the cannula were discarded by the patient.The physician ultimately opted to take a wait-and-see approach before scheduling a surgical removal.The physician reported some tenderness and redness at the affected site.The patient was scheduled to see a specialist in the upcoming 2-4 weeks.It was further reported that the patient followed up with the specialist.The specialist noted that the inflammation had resolved.There was some discoloration at the site however.This was considered abnormal given that several weeks had passed since the patient's initial consultation.The specialist recommended that the patient continue with the wait-and-see approach.The specialist also believed that the broken fragment was in-situ, and that there was potential for it to naturally be extruded without surgical removal.No further patient complications were reported in relation to this event.

Manufacturer Narrative

Correction: type of reportable event corrected from malfunction to serious injury.Evaluation results: four cadd cleo infusion devices were returned for investigation.The samples were visually inspected, at a distance of 12 to 24 inches and normal conditions of illumination.One of the samples was found to be broken.The customer reported product problem (fragmented device) was therefore confirmed.The product problem was attributed to a manufacturing problem.

• Brand Name: CADD CLEO INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10098926
• MDR Text Key: 193016903
• Report Number: 3012307300-2020-05304
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,user facility
• Type of Report: Initial,Followup
• Report Date: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 21-7230-24
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention