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

Catalog Number	CH-72
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although the device was requested to be returned for evaluation, it has not been received.Without the returned device, a probable cause is unable to be determined.
Event or Problem Description
It was reported that a chemoclave® vented vial spike, 13mm generated a leak during patient use.The reporter stated that "reconstituting a pembrolizumab, when turned upside down to put pembro liquid into syringe the pembro spike leaked all over staff members hand." it was unknown if the sample was available for investigation.The status of the product at the time of the event was unknown.There was patient involvement, but no harm was noted.
Additional Manufacturer Narrative
D9: device available for evaluation: no.The complaint of leaks on item ch-72 cannot be confirmed.Since no product samples, pictures, or videos were received for investigation.Without the return of the used sample, a comprehensive failure investigation cannot be performed, and probable cause cannot be determined.

• Brand Name: CHEMOCLAVE® VENTED VIAL SPIKE, 13MM
• 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: 20478257
• Report Number: 9617594-2024-01469
• Device Sequence Number: 20899594
• Product Code: ONB
• UDI-Device Identifier: 00840619053192
• UDI-Public: (01)00840619053192(17)280901(10)13774808
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K173477
• 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,Followup
• Report Date (Section B): 07/27/2025

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: CH-72
• Device Lot Number: 13774808
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2024
• Supplement Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2023
• 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: PEMBROLIZUMAB, UNKNOWN MFR
• Patient Sex: Unknown