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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.A lot number was provided, pending a device history lot review.Additional reporter: ever medical co., ltd.Lucy wu productsspecialist04@evermedical.Com.Tw tel: 886-2-2712-6611.
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 the ch3034, and pump set are loose that lead to leakage.The event occurred during infusion.There was chemo but did not come in contact with the patient or healthcare provider.The chemo spill was cleaned per facility protocol.The device was replaced without further problem.No issue was reported on the pump set.The device was not reprocessed / re sterilized.There was patient involvement, but no adverse event/patient harm, and no delay in critical therapy.
Additional Manufacturer Narrative
Investigation summary the complaint could not be confirmed by investigation.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 a cause cannot be determined.The device history record was reviewed and no nonconformities were found that would have led to the reported complaint.

• 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: 20813881
• Report Number: 9617594-2024-01714
• Device Sequence Number: 9934840
• Product Code: ONB
• UDI-Device Identifier: 00840619024116
• UDI-Public: (01)00840619024116(17)290301(10)13934072
• 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): 04/28/2025

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: 13934072
• 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: 11/01/2024
• Supplement Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 11/30/2024
• Supplement Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2024
• 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 CHEMOTHERAPY, UNK MFR; UNSPECIFIED PUMP SET, UNK MFR
• Patient Sex: Unknown