MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 30" (76 CM) APPX 3.6 ML, ADMIN SET W/20 DROP IN-LINE DRIP CHAMBER, CHEMOLOCK¿ AD; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CL4131
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation but investigation is not yet complete.
Event or Problem Description
The event involved a 30" (76 cm) appx 3.6 ml, admin set w/20 drop in-line drip chamber, chemolock¿ additive port, spiros¿ w/red cap where the customer reported that chemo drug, abraxane, leaks associated with the icu medical tubing.He event occurred at outpatient treatment facility.The leaking was either the spiros on the secondary tubing or the microclave on the primary tubing.All incidents involve leaking or occluded/alarming.Reportedly the rn hung chemo, attached the secondary tubing (from the pharmacy) to the clave on the primary line.As soon as rn opened the clamp on the secondary tubing, fluid leaked out from the spinning spiros.Rn was at chairside and immediately closed the clamps on the secondary tubing and turned off the plum pump.The liquid that leaked was milky white, resembles the abraxane.The abraxane bag, secondary and primary tubing were returned to the pharmacy and a new bag of abraxane was made.Upon hanging new bag, the nurse changed primary tubing as high likelihood of proximal occlusion.A medsun/medwatch report # (b)(4) was received and is attached.The customer reported 5 similar events from this facility.
Additional Manufacturer Narrative
The complaint of leaks on item cl4131 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.Lot history review was conducted, and no non-conformities were found that would have led to the reported condition on the complaint.

• Brand Name: 30" (76 CM) APPX 3.6 ML, ADMIN SET W/20 DROP IN-LINE DRIP CHAMBER, CHEMOLOCK¿ AD
• 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. ; CS
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 21981512
• Report Number: 9617594-2025-00934
• Device Sequence Number: 15591859
• Product Code: ONB
• UDI-Device Identifier: 00887709095779
• UDI-Public: 00887709095779
• 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,Followup
• Report Date (Section B): 10/09/2025

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: CL4131
• Device Lot Number: UNKNOWN
• 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
• Supplement Date Received by Manufacturer: 09/15/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 10/09/2025
• 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: ABRAXANE.; ICU MEDICAL TUBING.; MICROCLAVE, ICU MEDICAL, PRODUCT INFORMATION UNK.
• Patient Sex: Unknown