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

Model Number	CL2000S
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a chemolock¿ injector that had a chemotherapy, paclitaxel (taxol), spill during infusion, and it came in contact with the patient.It was reported that the clear plastic part of the chemolock that connects to the iv tubing, became unattached and that the tubing can unscrew from the chemolock.Furthermore, it was not a user error as they were able to replicate it 4 times.There was patient involvement, but no patient harm reported, and no medical interventions required.
Additional Manufacturer Narrative
The device was received for evaluation.The investigation is not yet complete.
Additional Manufacturer Narrative
Received one used.List #cl2000s, chemolock¿; lot #7880780.Received one used.Manufacturer unknown, infusion set; lot #unknown.Taxol, paclitaxel residuals observed in received two used with list #cl2000s and mating device.The complaint of disconnection can be confirmed.As received the spin feature of each chemolock was activated and spinning freely.One of the chemolock was attached to an unknown; however, the female luer was observed to be on loose on the male luer.It is unknown if the chemolock was re-attached after disconnection.There were no damages or anomalies observed.There was no spline damage.There was no damage observed on the male luer threads of the mating device.There was no damage observed on the female luer threads.Each chemolock exhibited unrestricted spin feature rotation.The samples showed no evidence of a shear tab malfunction.The measured torque values of the chemolocks met product performance specifications and would not result in a disconnection.The probable cause of the disconnection is unknown.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: CHEMOLOCK¿
• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 16335455
• Report Number: 9617594-2023-00073
• Device Sequence Number: 17860825
• Product Code: ONB
• UDI-Device Identifier: 00887709056992
• UDI-Public: (01)00887709056992(17)270801(10)7880780
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2023

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 Model Number: CL2000S
• Device Catalogue Number: CL2000S
• Device Lot Number: 7880780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2023
• Supplement Date Received by Manufacturer: 02/27/2023
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 03/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2022
• 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: PACLITAXEL (TAXOL), MFR UNK; UNSPECIFIED IV TUBING, MFR UNK
• Patient Sex: Unknown