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	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 - date of event - the date of event is unknown, and 01 oct 2025 has been used as a placeholder.The device is available for evaluation- it has not been received.The investigation is pending.
Event or Problem Description
Event occurred regarding a chemolock where it was reported that there was a chemolock detached from the primed line of a cisplatin bag.There was patient involvement, and there exposure to staff.There was also delay in therapy.
Additional Manufacturer Narrative
The reported event could not be confirmed.Received a photo from the customer showing the affected sample.No conclusions could be made from the photo.Without the return of the physical sample a comprehensive review could not be performed and a probable cause could not be determined.As lot number was unknown, device history record (dhr) review was not performed.
Additional Manufacturer Narrative
Corrected information can be found in section h6 health effect - impact code.

• 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: 23419645
• Report Number: 9617594-2025-02090
• Device Sequence Number: 9085283
• Product Code: ONB
• UDI-Device Identifier: 00887709056992
• UDI-Public: 00887709056992
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/15/2026

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: 10/07/2025
• Supplement Date Received by Manufacturer: 11/21/2025; 11/21/2025
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 12/08/2025; 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: CISPLATIN, MFR UNKNOWN
• Patient Sex: Unknown