MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. ONCOLOGY KIT W/60" (152 CM) APPX 2.2 ML, SMALLBORE EXT SET W/CHEMOLOCK¿ PORT, CL; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CL3960
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Event or Problem Description
The complaint/event involved a oncology kit w/60" (152 cm) appx 2.2 ml, smallbore ext set w/chemolock¿ port, clamp, anti-siphon valve, spiros®; chemolock¿; syringe transfer set w/microclave®, chemolock¿ port.The tubing reportedly fell out of the adaptor that connects to the blue connector.There was leakage of 5-fluorouracil (5fu) with ndc number (b)(4).A white powdery substance was observed all over the infusion bag.The patient was not aware that there was leaking until the they went back to the clinic for pump disconnection, which was almost 47 hours since the start of the infusion.There was no report of human harm.
Additional Manufacturer Narrative
Received six (6) new list# cl3960, oncology kit w/60" (152 cm) appx 2.2 ml, smallbore ext set w/chemolock¿ port, clamp, anti-siphon valve, spiros¿; chemolock¿; syringe transfer set w/microclave¿, chemolock¿ port; lot# 13919794.No visual damages or anomalies were observed.The returned new sets were tested and no leaks were observed, however, during a lot history review the lot showed defects which could lead to leaks.The probable cause is from a molding error in manufacturing.

• Brand Name: ONCOLOGY KIT W/60" (152 CM) APPX 2.2 ML, SMALLBORE EXT SET W/CHEMOLOCK¿ PORT, CL
• 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: 20799623
• Report Number: 9617594-2024-01701
• Device Sequence Number: 6933224
• Product Code: ONB
• UDI-Device Identifier: 00887709083271
• UDI-Public: (01)00887709083271(17)290301(10)13919794
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2025

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: CL3960
• Device Lot Number: 13919794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2024
• 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: 5-FLUOROURACIL (5FU), MFR UNK; UNSPECIFIED INFUSION PUMP, MFR UNK
• Patient Sex: Unknown