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	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation, however, it is not yet received.Additional contact - distributor.(b)(6).Taiwan.
Event or Problem Description
The event involved a 5" (13 cm) bag spike adapter w/spiros w/red cap, vented cap where the customer reported after infusing the 5fu chemotherapy, they found a blue scrap in the drip chamber.There was no bleedback, no biohazard, and the device was not reprocessed/ resterilized.There was patient involvement, but there was no delay in therapy and harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
Additional information: d9 - date returned to mfg 24jan2025.Investigation summary received one (1) used ch3034 bag spike adapter w/spiros connected to one (1) used list #unknown clave bag spike and one (1) used list #unknown, plum set for inspection.A piece of blue plastic was observed in the drip chamber.The fluid from the set was flushed and collected in a vacuum filtration system.The blue plastic particle was not able to flush through the plum set.The plum set was cut open and the particle was retrieved.A piece was found to be missing on the blue strap of the spiros.The area would not have made contact with the ch-14 during connection.It is unknown how the particulate entered the fluid path.The reported complaint can be confirmed.The probable cause of the particle is due to a loose piece on the spiros.It is unknown how the particle became loose from the spiros and entered the fluid path.A device history record lot # review could not be conducted because no lot number(s) was/were identified.

• 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: 21356669
• Report Number: 9617594-2025-00257
• Device Sequence Number: 12726281
• Product Code: ONB
• UDI-Device Identifier: 00840619024116
• UDI-Public: 00840619024116
• 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): 05/02/2025

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: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2025
• Supplement Date Received by Manufacturer: 04/04/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 5-FU CHEMOTHERAPY, MFR UNK
• Patient Sex: Unknown