MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 3ML SYRINGE W/SPINNING CHEMOLOCK¿ INJECTOR; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CL2003
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 - date of event - the date of event is unknown, and 01 dec 2025 has been used as a placeholder.
Event or Problem Description
A complaint was received with regards to a 3ml syringe with spinning chemolock injector in which it was reported that there was leaking.Patient involvement was not specified.There was no harm.
Additional Manufacturer Narrative
D9 - date returned to mfg: 1/6/2026.An unclear photo was shared by customer, where the items are inside the plastic bag, but no significant damage or anomalies are observed.Received: one (1) used.List #cl2003, 3ml syringe w/spinning chemolock¿ injector connected to one (1) used.List #cl-82, chemolock¿ 13mm closed vial spike connected to, eribulin mesylate injection 1mg/2ml vial.One (1) used.List #cl-82, chemolock¿ 13mm closed vial spike connected to, eribulin mesylate injection 1mg/2ml vial.Were returned for evaluation.As received no significant damage or anomalies were noted on the returned samples.The samples were tested according dfu instructions and no leaks were observed.Complaint of leaks cannot replicate during the test.

• Brand Name: 3ML SYRINGE W/SPINNING CHEMOLOCK¿ INJECTOR
• 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: 23864713
• Report Number: 9617594-2025-02324
• Device Sequence Number: 5329798
• Product Code: ONB
• UDI-Device Identifier: 00887709084704
• UDI-Public: 00887709084704
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2026

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: CL2003
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 01/27/2026
• 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
• Patient Sex: Unknown