MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CHEMOLOCK¿ BAG SPIKE WITH ADDITIVE PORT, CHEMOLOCK¿ PORT; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CL3955
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	11/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of a fluid splash cannot 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.Initial reporter (full) phone number: (b)(6).Additional contact: (b)(6).
Event or Problem Description
The complaint/event involved a chemolock¿ bag spike with additive port, chemolock¿ port.The reporter stated that when nurse disconnected the chemo lock iv tubing from mtx bag, fluid splashed from the chemo lock out into the nurses eye during a patient's infusion.There was no dripping noted from iv tubing or mtx bag after reconnection.Mtx was flushed with no further issues.

• Brand Name: CHEMOLOCK¿ BAG SPIKE WITH ADDITIVE PORT, CHEMOLOCK¿ PORT
• 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: 22040609
• Report Number: 9617594-2025-01044
• Device Sequence Number: 13035431
• Product Code: ONB
• UDI-Device Identifier: 00887709082502
• UDI-Public: (01)00887709082502(17)290701(10)14082855
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/16/2025

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: CL3955
• Device Lot Number: 14082855
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2024
• 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: INFUSION BAG OF MTX, MFR UNK
• Patient Sex: Unknown