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

Catalog Number 21-7231-24

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Inflammation (1932); Internal Organ Perforation (1987)

Event Date 08/06/2021

Event Type  Injury  

Manufacturer Narrative

No product was returned.We are unable to confirm the reported complaint.If the product is returned, smiths medical will reopen this complaint for further investigation.Dhr: a device history review was also conducted on the component lot numbers and no discrepancies were found.

Event Description

It was reported that a piece of the teflon needle got stuck in the patient's body (abrasion of the material), but could not be removed in the hospital.The risk of an inflammation in the body remains.

Manufacturer Narrative

This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No problems or issues were identified during the device history record review.

Event Description

Additional information follow up 13-aug additional information response 17-aug: the patient went to the hospital on (b)(6) 2021.A total of five doctors, three of them surgeons, looked at the abdomen to see where the remaining piece was located.They decided the surgical intervention was not reasonable because the remaining piece was not visible and the risk of inflammation would be far too high with a surgical intervention.The chance of finding the missing piece in the abdomen would be very small.The remaining piece will not be attempted to be removed for now, unless further complications occur, as there was still a risk of the area on the abdomen (where the remaining piece was located) becoming infected.The patient was treated with a subcutaneous pump therapy with immunoglobulin.Patients current state of health was ok.The increased risk of inflammation or encapsulation remains.Furthermore, the patient was very afraid to use further needles.

• Brand Name: CADD CLEO INFUSION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13652410
• MDR Text Key: 286442824
• Report Number: 3012307300-2022-04269
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586028403
• UDI-Public: 10610586028403
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K042172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/22/2023
• Device Catalogue Number: 21-7231-24
• Device Lot Number: 3624711
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention