MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 45" (114 CM) APPX 1.7 ML, SMALLBORE EXT SET W/SPIROS¿ W/RED CAP, ANTI-SIPHON VAL; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CL4151
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Event or Problem Description
The complaint involved a 45" (114 cm) appx 1.7 ml, smallbore ext set w/spiros¿ w/red cap, anti-siphon valve, clamp, y-connector w/chemolock¿ port, rotating luer.It was stated in the report that a patient experienced a small leak of 5fu while on cadd pump with cadd kit (cl4151).Customer says that it looks like the leak is happening at the y-site with chemolock port.There was patient involvement, no patient harm but there was a delay in therapy.In addition to the above entry, the customer became aware of the issue when the nurse noticed white powder substance on pump carrying pouch when patient returned for disconnect.The device was used for 2 days.
Additional Manufacturer Narrative
One (1) used.List #cl4151, 45" (114 cm) appx 1.7 ml, smallbore ext set w/spiros¿ w/red cap, anti-siphon valve, clamp, y-connector w/chemolock¿ port, rotating luer; lot #unknown.--> one (1) used.List #unknown, lsm cassette with fluorouracil; lot #unknown.One (1) used.List #unknown, microclave; lot #unknown.--> one (1) used.List #unknown, needle; lot #unknown.Leak residue was observed on the chemolock y-connector the reported complaint of a leak could be confirmed from the residue on the sample received.However, the leak was unable to be replicated during testing.The probable cause of the leak is unknown.A device history review (dhr) could not be conducted because no lot number(s) was/were identified.

• Brand Name: 45" (114 CM) APPX 1.7 ML, SMALLBORE EXT SET W/SPIROS¿ W/RED CAP, ANTI-SIPHON VAL
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 22117606
• Report Number: 9617594-2025-01126
• Device Sequence Number: 4109925
• Product Code: ONB
• UDI-Device Identifier: 00887709098381
• UDI-Public: 00887709098381
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K131549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2025

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: CL4151
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 07/22/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 5FU, MFR UNK.; CADD INFUSION KIT, MFR ICU MEDICAL.; CADD INFUSION PUMP, MFR ICU MEDICAL.
• Patient Sex: Unknown