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 CHEMOLOCK¿ DRIP CHAMBER,; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CL3011
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 30" (76 cm) appx 3.3 ml, 20 drop admin set w/integrated chemolock¿ drip chamber, spiros® w/red cap, hanger where the customer reported that hazardous drug leaks associated with the icu medical tubing.The leaking was believed to have occurred at either spiros on the secondary tubing or the microclave on the primary tubing.There was patient involvement and no adverse event reported as a consequence of this event.
Additional Manufacturer Narrative
One (1) new list# cl3011, 30" (76 cm) appx 3.3 ml, 20 drop admin set w/integrated chemolock¿ drip chamber, spiros® w/red cap, hanger was returned for evaluation.As received, no physical damage or anomalies were observed.No mating device was returned for evaluation.The sample was tested as procedure.The complaint of leaks cannot be confirmed or replicated.Lot history review was performed and no relevant discrepancies, anomalies or nonconformances were identified that might lead the condition reported by customer.

• Brand Name: 30" (76 CM) APPX 3.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK¿ DRIP CHAMBER,
• 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: 21981664
• Report Number: 9617594-2025-00935
• Device Sequence Number: 8572646
• Product Code: ONB
• UDI-Device Identifier: 00887709057012
• UDI-Public: (01)00887709057012(17)290801(10)14114306
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K131549
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2025

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: CL3011
• Device Lot Number: 14114306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 05/07/2025
• 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: MICROCLAVE, ICU MEDICAL, PRODUCT INFORMATION UNK; SPINNING SPIROS, ICU, PRODUCT INFO UNK
• Patient Sex: Unknown