MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SPINNING SPIROS¿, CLOSED MALE LUER; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CH2000S
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a spinning spiros¿, closed male luer where it was reported that when the patient was being connected to chemotherapy, it popped off right before chemo started.They would not reattach to tubing and spiros changed at that time.The drug involved was a normal saline.The primary tubing was not attached and sequestered after chemotherapy infusion (vincristine) and returned to them.There was patient involvement, no patient harm and a few minutes of delay in therapy.
Additional Manufacturer Narrative
The complaint of separation on item ch2000s cannot be confirmed.Since 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 probable cause cannot be determined.The device history record review couldn't be performed because the lot number for this complaint was unknown.Corrected information can be found in d10 concomitant products, e3 - initial reporter occupation and e4 - initial report sent to fda.
Additional Manufacturer Narrative
The device is available for evaluation- it has not been received.The investigation is pending.

• Brand Name: SPINNING SPIROS¿, CLOSED MALE LUER
• 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: 22021304
• Report Number: 9617594-2025-00995
• Device Sequence Number: 8733989
• Product Code: ONB
• UDI-Device Identifier: 00840619033903
• UDI-Public: (01)00840619033903
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2025

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: CH2000S
• Device Lot Number: UNKNOWN
• 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: 04/14/2025
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: NORMAL SALINE, MFR UNK; NORMAL SALINE, MFR UNK; UNSPECIFIED CHEMOTHERAPY, MFR UNK; UNSPECIFIED PRIMARY IV LINE, MFR UNK
• Patient Sex: Unknown