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

Catalog Number	CL2000S
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 - date of event - the date of event is unknown, and 01 mar 2025 has been used as a placeholder.D4 and h4 the lot#, expiration date, and manufacture date are unknown.The device has been requested for evaluation- it has not been received.The investigation is pending.
Event or Problem Description
A complaint was received regarding a chemolock¿ that experienced leakage during use.It was stated in the report that while they are pushing doxorubicin, they noted drops on gauze after feeling resistance.Chemolock was engaged.Looked like the leak was coming from chemolock adaptor that comes attached to syringe.
Additional Manufacturer Narrative
D9 - device available for evaluation: no.The complaint of leaks on item cl2000s 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) couldn't be performed due to the lot number for this complaint was unknown.

• Brand Name: CHEMOLOCK¿
• 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: 22800493
• Report Number: 9617594-2025-01676
• Device Sequence Number: 18340354
• Product Code: ONB
• UDI-Device Identifier: 00887709056992
• UDI-Public: 00887709056992
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2025

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: CL2000S
• Device Lot Number: UNKNOWN
• 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: 03/19/2025
• Supplement Date Received by Manufacturer: 09/08/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 10/02/2025
• 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: DOXORUBICIN, MFR UNKNOWN.
• Patient Sex: Unknown