MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CHEMOLOCK¿ 13MM CLOSED VIAL SPIKE; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CL-82
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Chemical Exposure (2570)
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 is available for evaluation- it has not been received.The investigation is pending.
Event or Problem Description
Event occurred regarding a chemolock 13mm closed vial spike where it was reported that the tech went to spike the adapter onto the vial and the spike broke off.There was patient involvement, and staff exposure.There was also delay in therapy.
Additional Manufacturer Narrative
One photo was received for evaluation and no defects or anomalies were noted.One used device was also received for evaluation; as received the vial spike was broken.Examination of the break area showed cold form damage.One side was higher than the other, typical of a bend break.The reported complaint can be confirmed.The probable cause is due to an unintentional bending force during use.The directions for use stated, "place vial on hard surface (counter), remove end cap from chemolock vial spike (if applicable) and align spike with center of vial closure.Push spike straight into center of vial stop." the lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaints.

• Brand Name: CHEMOLOCK¿ 13MM CLOSED VIAL 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: 23432747
• Report Number: 9617594-2025-02106
• Device Sequence Number: 11945276
• Product Code: ONB
• UDI-Device Identifier: 00887709085695
• UDI-Public: (01)00887709085695(17)300701(10)14502293
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2025

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-82
• Device Lot Number: 14502293
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2025
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2025
• 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