MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 5" (13 CM) BAG SPIKE ADAPTER W/SPIROS¿ W/RED CAP, VENTED CAP; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CH3034
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No ch3034 product samples were returned for investigation.One photograph was provided by the customer for evaluation.One photo confirms the complaint of the above of the tube broke.The device history lot number review for lot number 13743456 was reviewed and there were no non-conformances found that would have contributed to the reported complaint.The customer complaint can be confirmed from the photograph provided.A probable cause cannot be identified based on the information that has been provided.
Additional Manufacturer Narrative
Device not available for evaluation.A picture and lot number were provided.Investigation is pending.Additional reporter: (b)(6).
Event or Problem Description
The event involved a 5" (13 cm) bag spike adapter w/spiros¿ w/red cap, vented cap where it was reported during drug infusion, the tube broke.The event occurred during infusion.Device was not reprocessed/resterilized.The package sealed fully.There was no problem after replacing the sample.There was patient involvement, however no report of harm or delay in therapy.

• Brand Name: 5" (13 CM) BAG SPIKE ADAPTER W/SPIROS¿ W/RED CAP, VENTED CAP
• 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: 21232191
• Report Number: 9617594-2025-00183
• Device Sequence Number: 11833914
• Product Code: ONB
• UDI-Device Identifier: 00840619024116
• UDI-Public: (01)00840619024116(17)280801(10)13743456
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2025

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: CH3034
• Device Lot Number: 13743456
• 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: 12/30/2024
• Supplement Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: CYCLOSPORINE, UNK MFR.
• Patient Sex: Unknown