MAUDE Adverse Event Report: . 14" (36 CM) APPX 4.3 ML, BIFUSE ADD-ON SET W/BAG SPIKE, SPIROS® W/RED CAP, 2 CLA; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CH3661
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Event occurred regarding to 14" (36 cm) appx 4.3 ml, bifuse add-on set w/bag spike, spiros w/red cap, 2 clamps (blue, red), vented cap, drop-in spiros w/red cap where it was reported that the spiros that attached to the bifuse (not the spinning one at the bottom), came partially detached and was able to move up and down on the tubing when it¿s usually fixed in place.They also reported chemo leaked due to this separation.There was patient involvement, no patient harm and there was delay in therapy.
Additional Manufacturer Narrative
The device is available for evaluation- it has not been received.The investigation is pending.
Additional Manufacturer Narrative
One used sample connected to an unknown, infusion set were returned for evaluation.Visual and functional testing was conducted.As received, no physical damage only one of the spiros was not properly connected with the unknown infusion set, this happened because the spinning mechanics was already activated, making not possible to connect with the threads of the mating device.The shear tab was activated correctly and no damage on the splines were observed.The set was tested as received and no leaks were noted.The torque residual was found within specification.The female and male luer met iso complaint specification.As received, the icu medical was functional tested and no leaks or disconnections were noted.However, the unknown infusion set was not properly engaged.The reported event was not confirmed, and the probable cause is unable to be determined.D9: date returned to mfg.: 12/1/2025.

• Brand Name: 14" (36 CM) APPX 4.3 ML, BIFUSE ADD-ON SET W/BAG SPIKE, SPIROS® W/RED CAP, 2 CLA
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): .; 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: 23639143
• Report Number: 9617594-2025-02212
• Device Sequence Number: 9259119
• Product Code: ONB
• UDI-Device Identifier: 00887709086883
• UDI-Public: 00887709086883
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2025

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: CH3661
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 12/29/2025
• 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: UNKNOWN CHEMO DRUG, UNK MFR
• Patient Sex: Unknown