MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 30" (76 CM) APPX 3.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOCLAVE® DRIP CHAMBE; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CH3011
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is reported to be available for evaluation; however, it has not yet been received.
Event or Problem Description
The event involved a 30" (76 cm) appx 3.3 ml, 20 drop admin set w/integrated chemoclave® drip chamber, spiros® w/red cap, bag hanger, where the luer lock gasket or ball is not springing back to reseal as it should, resulting in the valve to stay open and are incomplete, easily reversible connections.They stated that the spiros will click as it normally does when it is locked but then will easily disconnect and fall off the syringe.They stated that drug wasted from the bags, leaking out of the unsealed valve.There was no patient harm and unknown delay in therapy as a result of this event.The event occurred on an unspecified date.
Additional Manufacturer Narrative
D9 device received for evaluation on 6/4/2025.Investigation summary: received one (1) used ch3011 admin set w/integrated chemoclave drip chamber, spiros, one (1) used list# unknown 50ml syringe, and one (1) used list# unknown spiros for inspection.As received, the spiros was activated and freely spinning and separated from the syringe.No spline or shear tab anomalies noted.Each of the spiros had the poppet in the inactivated position.Each set and spiros were activated and leak tested and then deactivated and leak tested.There was no leakage or defects.The reported complaint was unable to be replicated or confirmed on the ch3011.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 30" (76 CM) APPX 3.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOCLAVE® DRIP CHAMBE
• 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: 22179171
• Report Number: 9617594-2025-01181
• Device Sequence Number: 15593998
• Product Code: ONB
• UDI-Device Identifier: 00840619023966
• UDI-Public: (01)00840619023966(17)291101(10)14228162
• Combination Product (Y/N): N
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2025

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: CH3011
• Device Lot Number: 14228162
• 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: 05/14/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2024
• 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 DRUG
• Patient Sex: Unknown