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	04/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4 and h4 the lot#, expiration date, and manufacture date are unknown.E1 - this complaint was received through: (b)(6).Investigation summary: a couple of photos were shared by customer.Where a syringe is observed full of liquid, the chemolock and the chemosafe port are disconnected, no additional damage or anomalies are shown.One (1) used list# cl2100, chemolock¿ port connected to an unknown, chemo port connected to one (1) used, 1ml syringe were returned for evaluation.As received methotrexate and normal saline residual was observed.The chemosafe and chemoport were primed, using the hydrostatic pressure pump: at gravity pressure and no anomalies, occlusion or flow restriction were noted.Then the pressure was increased till 25 psi and no leaks were confirmed.The samples were dissembled and no anomalies were found.Complaint of defective / malfunctioning cannot be confirmed or replicated.A device history record lot# review could not be conducted because no lot number(s) was/were identified.
Event or Problem Description
A complaint was received regarding a chemolock¿ port with item number cl2100 that was associated with backflow resulting in leakage through syringe.It was reported that when the staff was about to administer methotrexate, the chemolock malfunctioned.Additionally, upon locking the chemo syringe onto the port that was on the primary line suddenly noticed rapid back flow of normal saline into the chemo syringe, because this happened rapidly and because the volume of methotrexate was so small (0.3ml) the plunger was pushed out of the syringe and a small amount of methotrexate spilled onto a blue pad that was under the chemo syringe.The event occurred on 22-apr-2025 during administration.There was patient involvement and no human harm.It was noted that the syringe and chemolock used.0.3ml was the initial volume, when attached to port and saline line, saline push back into syringe.A sample picture was provided showing the product.It was noted that the manufacturer of normal saline is baxter and the ndc number is b1322 with din 00060208, there are no issues related to the ns.

• 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. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 22093189
• Report Number: 9617594-2025-01109
• Device Sequence Number: 6906538
• 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
• Type of Report: Initial
• Report Date (Section B): 05/27/2025

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: 05/14/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 05/27/2025
• 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
• Patient Sex: Unknown