MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CHEMOCLAVE¿ BAG SPIKE W/PORT, DRY SPIKE; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	011-CH-12
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2024
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 cl-21.This product was used for the di and 501k.Investigation summary: three pictures were returned showing a syringe connected to the blue clave of the spike and the area of the break.The spike leur can be seen still inside the bonding pocket.The deformation area appears to be at a slight angle.The complaint of broken set can be confirmed based on the returned image.The probable cause is due to unintentional bending forces applied during use.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.
Event or Problem Description
An event involving a chemoclave¿ bag spike w/port, dry spike ln 011-ch12 experienced leakage.The initial reporter stated that the set had broken, and the piece was kept in the syringe, when they went to wash the line with saline solution by introducing it through the ch-12.The sample is not available for evaluation, it was contaminated or contained some biohazard or chemotherapeutic agent, and it was not reprocessed or re-sterilized prior to use.The product status was during use, for 1 hour, with a patient.The affected sample ch-12 was discarded since it came in contact with a potentially toxic investigational (clinical trial) medication.An interleukin-2 (il-2) variant protein medication was used with the product.Three pictures were provided showing the product.The event occurred during patient use and there was delay in therapy.However, there was no adverse event and no one was harmed as a result of this event.

• Brand Name: CHEMOCLAVE¿ BAG SPIKE W/PORT, DRY 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: 20018328
• Report Number: 9617594-2024-01165
• Device Sequence Number: 18284226
• Product Code: ONB
• UDI-Device Identifier: 00887709121195
• UDI-Public: 00887709121195
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 08/19/2024

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: 011-CH-12
• Device Lot Number: 13890957
• 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: 07/03/2024
• Initial Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2024
• 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
• Patient Sex: Unknown