MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CHEMOLOCK¿ 13MM CLOSED VIAL SPIKE; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CL-82
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation as the customer has discarded it.Without the return of the device, a probable cause is unable to be determined.
Event or Problem Description
The event involved a chemolock¿ 13mm closed vial spike in which the customer reported that as the nurse was mixing a bacille calmette-guerin (bcg) dose with verity brand which requires reconstitution of 2 vials into one syringe.Diluent was added to both vials to begin with so it could dissolve the powdered drug.Then the nurse removed the drug from one vial, then the other.When attempting to inject the air from the syringe back into the 2nd vial, the air kept pushing back into the syringe.So the nurse was unable to remove the air from the syringe.There were no defects noted on the tubing set before it was used.The drug was delivered to the patient.It was intended for bladder instillation.There was patient involvement but no harm was reported as a consequence of this event.

• Brand Name: CHEMOLOCK¿ 13MM CLOSED VIAL 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: 17999266
• Report Number: 9617594-2023-00880
• Device Sequence Number: 5831001
• Product Code: ONB
• UDI-Device Identifier: 00887709085695
• UDI-Public: (01)00887709085695(17)280101(10)13515859
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/27/2023

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: CL-82
• Device Lot Number: 13515859
• 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: 09/27/2023
• Initial Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2023
• 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: 50 CC SYRINGE, MFR UNK.; BCG DOSE, MFR UNK.; CL 2000S, ICU MEDICAL.
• Patient Sex: Unknown