MAUDE Adverse Event Report: ICU MEDICAL, INC CADD EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-7106-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 information becomes available.
Event or Problem Description
It was reported that patient stated that her gown sleeve felt wet.The iv tubing was traced up to the pump, which was infusing fluids and when the cadd tubing was slightly flexed, fluid was seen spurting from the tubing.The pump was stopped and the tubing was disconnected from the iv.The tubing was flushed with a saline syringe to clear remaining medication, then bagged and taken by the rn to show administration.The patient was awake and sitting in bed.No patient harm was reported.
Additional Manufacturer Narrative
D3 - postal code: updated.D9 - date returned to mfr: 4/6/2026.H3 and h6 codes - updated.One used device was returned for investigation.The device was visually inspected and found no physical damage or other anomalies were observed.During the functional testing, a leak was observed from the y junction during the pressure ramp, at 1 psi.Upon further investigation, a channel was observed at the junction that is the cause for the leak.The complaint of leakage can be confirmed.The probable cause is solvent application error during assembly.A device history record (dhr) review could not be performed as the lot number was unknown.

• Brand Name: CADD EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24748762
• Report Number: 3012307300-2026-03116
• Device Sequence Number: 18433279
• Product Code: FPA
• UDI-Device Identifier: 10610586023279
• UDI-Public: (01)10610586023279
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K974013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2026

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: 21-7106-24
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Supplement Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown