MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7.5" (19 CM) APPX 1.1 ML, BIFUSE EXT SET W/CHEMOLOCK¿ PORT, CHEMOCLAVE®, SPIROS®; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CL3932
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E tab initial reporter - the complaint came through: (b)(6).Investigation summary: the reported complaint of a leak could not be confirmed.Without the return of the sample or a photo/video, a comprehensive investigation cannot be performed and a probable cause cannot be determined.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.
Event or Problem Description
A complaint was received with regards to a 7.5" (19 cm) appx 1.1 ml, bifuse ext set w/chemolock¿ port, chemoclave¿, spiros¿, 2 clamps that experienced leakage.The reporter stated that chemolock y connected to axatilimab & ns lines, then connected to patient.Axatilimab infusion initiated.Leak noted from connection at base of chemolock to y tubing, medication pooling on patient's bed.Infusion stopped & chemolock y changed.Spill cleaned up appropriately.Infusion resumed with no issue.There was patient involvement and no adverse event.Lost small amount of medication but not significant.

• Brand Name: 7.5" (19 CM) APPX 1.1 ML, BIFUSE EXT SET W/CHEMOLOCK¿ PORT, CHEMOCLAVE®, SPIROS®
• 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: 20641493
• Report Number: 9617594-2024-01582
• Device Sequence Number: 7367229
• Product Code: ONB
• UDI-Device Identifier: 00887709077621
• UDI-Public: (01)00887709077621(17)281201(10)13856643
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 11/08/2024

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: CL3932
• Device Lot Number: 13856643
• 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: 10/09/2024
• Initial Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/20/2023
• 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: AXATILIMAB, MFR UNKNOWN.
• Patient Sex: Unknown