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 Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.A device history lot review cannot be performed due to no lot number provided.D4: only di provided as lot number is unknown.
Event or Problem Description
The event occurred on an unspecified date and involved a chemolock port.It was reported the cl2100 is coming disconnected from the needleless connectors on the y-site of their b braun pump tubing (caresite needle-free connector) and nexus connector that is on the patient's central line.When the cl2100 pops off the needleless connector while connected to the cl2000s, this results in a chemo spill/exposure.The leak was coming from the y connector and the hub at the patient with the nexus tko.There was patient involvement and unknown adverse event.
Additional Manufacturer Narrative
The customer returned a diagram for evaluation, showing the whole set connection and the source of the leak when the device cl2100 is connected into a chemosafe lock.However, in the picture no leaks or drops of water are shown.Complaint of disconnection / loose connection cannot be confirmed.Without the return of the used sample, a comprehensive failure investigation cannot be performed, and probable cause cannot be determined.Lot history review could not be performed due to the lot number for this complaint was unknown.

• 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: 22994461
• Report Number: 9617594-2025-01813
• Device Sequence Number: 8914433
• Product Code: ONB
• UDI-Device Identifier: 00887709057005
• UDI-Public: 00887709057005
• 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: User Facility
• Initial Reporter Occupation: Other
• 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: CL2100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2025
• Supplement Date Received by Manufacturer: 09/11/2025
• Initial Report FDA Received Date: 09/08/2025
• Supplement Report FDA Received Date: 10/02/2025
• 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: B BRAUN PUMP TUBING(CARESITE NEEDLE-FREE CONNECTO; CENTRAL LINE CATHETER, UNK MFR; NEXUS CONNECTOR; UNSPECIFIED CHEMOTHERAPY, UNK MFR
• Patient Sex: Unknown