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 Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	08/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation.Investigation is pending.
Event or Problem Description
The event involved a chemolock¿ in the oncology infusion clinic and occurred during preparation.It was reported that the cl2000s is being attached to bd primary pump tubing.The injector is added to the tubing; clinician can hear the crack and then the injector spins freely indicating attached.The injector then comes loose or disconnects causing leaks and in some cases chemo spills.This have been occurring on and off for the past 3 weeks.There was a code orange: a hazardous material spill or release which happened multiple times.No one was harmed as a result of event but there was chemo exposure to clinicians.The event resulted to delay in therapy.There was no human harm reported.
Additional Manufacturer Narrative
Photo provided showing the packaging information.No defects or anomalies noted.Received nine (9) new cl2000s chemolock for inspection.No defects or anomalies noted.The chemolocks were functionally tested and found to meet performance specifications.The reported complaint was unable to be replicated or confirmed.Without the return of the used sample a comprehensive failure investigation cannot be performed.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.

• 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: 22994272
• Report Number: 9617594-2025-01812
• Device Sequence Number: 21212213
• Product Code: ONB
• UDI-Device Identifier: 00887709056992
• UDI-Public: (01)00887709056992(17)300401(10)14391932
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2025

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: 14391932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2025
• Supplement Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 09/08/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2025
• 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: BD PRIMARY PUMP TUBING.; UNSPECIFIED CHEMOTHERAPY, UNK MFR.
• Patient Sex: Unknown