MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 8" ADD-ON SET, BAG SPIKE W/CLAVE® ADDITIVE PORT, CHEMOLOCK¿ PORT, DRY SPIKE ADAP; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CLH-12
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint on item clh-12 cannot be confirmed.Since no product samples, pictures, or videos were received for investigation.Without the return of the used sample, a comprehensive failure investigation cannot be performed, and probable cause cannot be determined.The device history review (dhr) lot# was reviewed, and no non-conformities were found that would have led to the reported condition on the complaint.
Event or Problem Description
An email was received with regards to an 8" add-on set, bag spike w/clave® additive port, chemolock¿ port, dry spike adapter, alleging an unspecified chemotherapy spill during patient use.It was reported that there was a user error resulting in a chemo spill.The spill happened as the nurse went to connect the tubing to the patient.The intravenous (iv) spike fell out of the dry spike adapter due to the pharmacy tech not fully twisting the spike into the dry spike.Notable barrier: multiple shoulder/wrist repetitive use injuries occurring in the pharmacy due to the force with which one has to use to insert the spike into the dry spike adapter.The patient and another registered nurse (rn) in the room were dizzy and sent to occupational health, and there was a delay in therapy.

• Brand Name: 8" ADD-ON SET, BAG SPIKE W/CLAVE® ADDITIVE PORT, CHEMOLOCK¿ PORT, DRY SPIKE ADAP
• 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: 23424136
• Report Number: 9617594-2025-02093
• Device Sequence Number: 20896442
• Product Code: ONB
• UDI-Device Identifier: 00887709080416
• UDI-Public: (01)00887709080416(17)270601(10)6033734
• Combination Product (Y/N): N
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/30/2025

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: CLH-12
• Device Lot Number: 6033734
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2022
• 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: UNSPECIFIED CHEMO, UNK MFR
• Patient Sex: Unknown