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

Catalog Number	CH-51
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.E1 initial reporter phone number: (b)(6).
Event or Problem Description
The event occurred on an unspecified date and involved a universal vented vial spike, clave® where it was reported, the blue foreign piece you see on the tampon was in the side hole of the spike and you also see some still in the hole.This occurred when the 'universal vented vial spike, clave' was unpacked.This is a product that they use to put on their oncology vials.There was unknown patient involvement and unknown patient harm.
Additional Manufacturer Narrative
Complaint of particulate matter can be confirmed based on the photos shared by customer.However, without the returned of the small blue particulate a comprehensive failure investigation cannot be performed and a probable cause cannot be determined.The device history review (dhr) lot#13671971 was reviewed and no nonconformities were found that would have led the reported condition on the complaint.

• Brand Name: UNIVERSAL VENTED VIAL SPIKE, CLAVE®
• 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: 18026876
• Report Number: 9617594-2023-00894
• Device Sequence Number: 7615357
• Product Code: ONB
• UDI-Device Identifier: 00840619025779
• UDI-Public: (01)00840619025779(17)280601(10)13671971
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2023

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-51
• Device Lot Number: 13671971
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2023
• Supplement Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 10/29/2023
• Supplement Report FDA Received Date: 12/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2023
• 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: UNSPECIFIED ONCOLOGY VIALS, UNK MFR.
• Patient Sex: Unknown