MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 8" (20 CM) APPX 0.43 ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAM; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CH3367
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved an 8" (20 cm) appx 0.43 ml, smallbore bifuse ext set w/2 microclave¿ clear, 2 clamps, spiros¿ where the customer stated that the device was previously running chemotherapy and fluids, and when the nurse went to check blood return in between chemotherapies, the nurse was able to obtain blood return by pulling back on a syringe but unable to flush anything.The nurse disconnected the y-site tubing from the patient.The patient's line was working fine, with good blood return.There was no patient harm or adverse event as a result of this event.A mdr report #mw5169769 was received on 14-may-2025.
Additional Manufacturer Narrative
It is unknown if the device will be returned for evaluation, however, attempts are being made to obtain same.A lot history review should be performed.
Additional Manufacturer Narrative
The reported complaint of unable to flush could not be confirmed.Without the return of the sample or a photo/video a comprehensive review cannot be performed and a probable cause cannot be determined.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.Corrected information can be found in d10 concomitant products and e3 - initial reporter occupation.

• Brand Name: 8" (20 CM) APPX 0.43 ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAM
• 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: 22201803
• Report Number: 9617594-2025-01236
• Device Sequence Number: 7723470
• Product Code: ONB
• UDI-Device Identifier: 00840619060657
• UDI-Public: (01)00840619060657(17)290801(10)14113936
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K173477
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2025

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: CH3367
• Device Lot Number: 14113936
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/18/2024
• 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: CHEMOTHERAPY AND FLUIDS, MFS UNK.; CHEMOTHERAPY AND FLUIDS.; UNSPECIFIED SYRINGE, MFR UNK.
• Patient Age: 16 YR
• Patient Sex: Male