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

Catalog Number	CL-14
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 - date of event - the date of event is unknown, and 01 oct 2025 has been used as a placeholder.The device has been received for evaluation.The investigation is pending completion.
Event or Problem Description
Event occurred regarding a chemolock vented bag spike where it was reported that they found bags spikes in the wrong packaging labeled as cl-14 bag spike however, the package is a non-vented cl-10.There was no patient involvement.
Additional Manufacturer Narrative
Investigation summary: a photo was shared by the customer, where a unit with no filter vent is observed inside a sealed package, label as cl-14.However, based on the cl-14 configuration, this should've a filter vent, in the photo is no shown.No additional anomalies are observed.Four (4) new.List #cl-14, chemolock¿ vented bag spike; lot #14426526 were returned for evaluation.As received, no filter vent on the spike was noted, according the item configuration this sets should've one.The sets inside the sealed packaged didn¿t match with the expected configuration.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.The complaint of labeling does not agree with the type of product, can be confirmed based on the returned sample evidence.The probable cause was due to a mixing error during the packaging process at ensenada.

• Brand Name: CHEMOLOCK¿ VENTED BAG 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: 23420259
• Report Number: 9617594-2025-02091
• Device Sequence Number: 13398327
• Product Code: ONB
• UDI-Device Identifier: 00887709063235
• UDI-Public: (01)00887709063235(17)300501(10)14426526
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2025

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: CL-14
• Device Lot Number: 14426526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2025
• 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