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

Catalog Number	CL2100
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.
Event or Problem Description
The complaint/event occurred on an unspecified date and involved a chemolock¿ port that reportedly leaked a few drops of chemotherapy.During an infusion, the patient alerted the nurse that the lines had come undone.When the nurse went to look into the issue, it was identified that the female and male connectors on the chemolocks came apart.Luckily, the patient was able to spot the issue and report it quickly (which averted a full chemo spill).The nurse knew that the pieces were connected before they left the room.The nursing staff reconnected the pieces to investigate, and they were able to be pulled apart very easily.The staff changed out that part of the line.The next (replacement) female and male connectors fit more securely and were not able to be pulled apart.There was no human harm was associated with this event.
Additional Manufacturer Narrative
One photo was shared by the customer, where the item and lot information from the item #cl2100 was observed.No damage or anomalies are confirmed.Twenty-nine new samples item #cl2100, were received for evaluation.As received no physical damages or anomalies were observed.The samples were tested as per procedure and no leaks or anomalies were confirmed.The male luer were confirmed to comply with iso design expectations.Complaint of leaks cannot be confirmed or replicated.Date returned to mfg:10jan2024.

• Brand Name: CHEMOLOCK¿ PORT
• 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: 18509567
• Report Number: 9617594-2024-00029
• Device Sequence Number: 7900985
• Product Code: ONB
• UDI-Device Identifier: 00887709057005
• UDI-Public: (01)00887709057005(17)281001(10)13797343
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 01/31/2024

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: CL2100
• Device Lot Number: 13797343
• 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: 12/22/2023
• Supplement Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 01/13/2024
• Supplement Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2023
• 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: UNSPECIFIED CHEMOTHERAPY, MFR UNK
• Patient Sex: Unknown