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

Catalog Number	CL2100
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for evaluation- it has not been received.The investigation is pending.
Event or Problem Description
Event occurred regarding a chemolock port where they reported that doxorubicin was administered through pvad with chemolock connector and compatible syringe connector, and when disconnected to begin next syringe, the chemolock leaked about a quarter sized amount of drug onto absorbent pad.They further mentioned that the nurse was sure the port was connected properly to the iv tubing connector when they injected the doxorubicin hd with injector cl2000s on syringe.There was patient involvement, and no adverse event reported.
Additional Manufacturer Narrative
Received one used list# cl2100 chemolock port for inspection.No defects or anomalies noted.The cl2100 was leak tested per product specifications in the inactivated state and when connected to an icu medical provided chemolock.There was no leakage.The reported complaint was unable to be replicated or confirmed.The possible lot history records for possible lots 14135122, 14186032 were reviewed, no nonconformities were identified that may have contributed to the reported complaint.Corrected information can be found in d10 concomitant products, e3 - initial reporter occupation, e4 - initial report sent to fda and h6 component code.

• Brand Name: 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. ; MX
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 22842286
• Report Number: 9617594-2025-01704
• Device Sequence Number: 17375163
• Product Code: ONB
• UDI-Device Identifier: 00887709057005
• UDI-Public: 00887709057005
• 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): 10/22/2025

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: CL2100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Supplement Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 10/22/2025
• 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: CHEMOLOCK¿ LIST CL2000S, MFR ICU MEDICAL; DOXORUBICIN, MFR UNKNOWN; DOXORUBICIN, MFR UNKNOWN; UNSPEC PVAD (PERIPH. VENOUS ACCESS DEVICE) MFR UNK; UNSPECIFIED SYRINGE, MFR UNK
• Patient Sex: Unknown