MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. CADD CLEO INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-7221-24
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: unknown; no information has been provided to date.H3: investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that the cleo catheter tip had been found broken off from the patient's two most recent site and the location of the lodged fragment had remained unknown.They had believed the issue to be a defect associated with cleo lot (expiration date unknown).They had stated that the patient had been seen by the physician after the first occurrence and had followed up accordingly.The father had further reported that the physician had advised monitoring the site for redness, itching, or infection, and that an ultrasound might be required.The father had declined the ultrasound, electing instead to wait, and had stated that the area appeared healed.They had also reported that the area beneath the catheter site had felt somewhat firm but otherwise normal.The registered pharmacist (rph) had advised the father to follow up with the physician¿s office regarding an ultrasound, and a clinical nurse specialist (cns) had been assigned to review the details.The rph had also instructed the father to call 911 if the issue were to recur.The patient¿s current remodulin dose had been 100 ng per kg per min subcutaneously.The patient had been self-filling remunity via the remunity pump and had begun using the remunity device in 2025.Patient details were provided: the patient's initials are (b)(6), a female, born on (b)(6) 2022 and the height is 2¿ 11.

• Brand Name: CADD CLEO INFUSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V.; avenida calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24500727
• Report Number: 3012307300-2026-01969
• Device Sequence Number: 18752007
• Product Code: FPA
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K042172
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 21-7221-24
• Device Lot Number: 6092951
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Supplement Date Received by Manufacturer: 06/29/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 07/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 3 YR
• Patient Sex: Female