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

Catalog Number	CL-12
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been requested for evaluation.It has not been received.The investigation is pending.
Event or Problem Description
A complaint was received with regards to a chemolock bag spike with additive port, dry spike in which it was reported that there was a chemo spill.The event occurred when the rn attempted to hang the bag.The rn spilled chemo agent over her arm while wearing personal protective equipment (ppe).There was no patient harm.
Additional Manufacturer Narrative
One used chemolock¿ bag spike w/additive port, dry spike, one used 0.9% sodium chloride 250ml bag, one used extension set, one used chemolock connector was received for evaluation.The device was visually inspected.There were no anomalies noted upon visual inspection.The sample was pressure leak tested at 25psi with no leaks observed.The reported complaint of the bag spike disconnecting could not be confirmed.The spike was measured and was within the dimensional specifications.The returned sample was tested and was within product specifications.A device history review (dhr) lot # review could not be conducted because no lot number was identified.D9 - date returned to mfg: 11/18/2025.

• Brand Name: CHEMOLOCK¿ BAG SPIKE WITH ADDITIVE PORT, DRY SPIKE
• 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: 23543361
• Report Number: 9617594-2025-02160
• Device Sequence Number: 18544212
• Product Code: ONB
• UDI-Device Identifier: 00887709056978
• UDI-Public: 00887709056978
• 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): 01/06/2026

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: CL-12
• 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: 10/29/2025
• Supplement Date Received by Manufacturer: 12/29/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 01/06/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED CHEMO INFUSATE, MFR UNK
• Patient Sex: Unknown