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

Model Number	7022
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	06/26/2025
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 a blood and 5-fu chemotherapy had been leaking from the patient¿s continuous iv pump.The leak had been stated to originate from the connection.The patient had been advised to return the pump to the infusion site upon discharge.The tubing had likely been disposed of.The continuous infusion had been initiated on (b)(6) 2025 with a total reservoir volume of 138 ml, administered at a rate of 3 ml/hr over a 46-hour period; the pump had not been used to prime the extension tubing, as the line had been manually primed using a syringe, and the patient had subsequently been advised to visit the emergency room and was admitted for monitoring due to skin irritation.There was patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
D3 mfr establishment name: correction.D9: date returned to mfg.: 8/19/2025.H3 and h6.Codes: updated.Device evaluation: received one (1) used lock port and one (1) used administration set.As received, there was some dried residuals in the tubing that appeared to be crystalized.Attached the returned administration set to the pressure pump, unable to establish any flow in order to look for reported complaint of leaking.Unable to replicate or confirm customer complaint of leaking.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

• Brand Name: CADD ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22564910
• Report Number: 3012307300-2025-08713
• Device Sequence Number: 21168976
• Product Code: FPA
• UDI-Device Identifier: 10610586019791
• UDI-Public: (01)10610586019791(17)291024(10)6070546
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K895046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2026

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 Model Number: 7022
• Device Catalogue Number: 21-7022-24
• Device Lot Number: 6070546
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2025
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 5FU.
• Patient Sex: Unknown