MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CHEMOSAFELOCK BAG SPIKE; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	KL-BS001U3
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4, g4: model number is not sold in the us but similar device is sold under model ch-10.This product was used for the di, product code, and 501k.E1.Addtional contact: (b)(6).The device has been requested for evaluation- it has not been received.The investigation is pending.
Event or Problem Description
A complaint was received regarding a chemosafelock bag spike that experienced leakage.It was stated in the report, ¿leakage¿.Translated from japanese: "a patient receiving cyramza via chemosafelock experienced leakage from the connection between the bag spike and the infusion set.After connecting the bag spike and the route, the nurse was observing the infusion for about five minutes when leakage occurred from the bag spike.".
Additional Manufacturer Narrative
D9 device returned to manufacturer on 8/1/2025.One (1) used list #kl-bs001u3, chemosafelock bag spike was returned for evaluation.As received, an incomplete insertion between the spike into the chemolock was observed.The returned set was primed and a leaks between the spike and the chemolock bond was confirmed.Complaint of leaks can be confirmed.The probable cause is an error during assembly process.A device history lot # review could not be conducted because no lot number(s) was/were identified.

• Brand Name: CHEMOSAFELOCK BAG SPIKE
• 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: 22779819
• Report Number: 9617594-2025-01657
• Device Sequence Number: 12794081
• Product Code: ONB
• UDI-Device Identifier: 00840619023676
• UDI-Public: 00840619023676
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 09/10/2025

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: KL-BS001U3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Supplement Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 09/10/2025
• 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: CYRAMZA INFUSION, MFR UNKNOWN.
• Patient Sex: Unknown