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 Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One used sample list #cl2100, chemolock connected to one (1) used infusion set and one (1) used, 0.9% sodium chloride injection were returned for evaluation.No physical damage or anomalies were observed.As returned, the sample was tested in different configurations and only with the returned configuration (the returned chemolock port + bd male luer port), failed the flow rate specifications.No additional damage or anomalies were observed.The male luer of the icu chemolock port was found to meet the iso standard of luer dimension, and when isolated, was found to meet flow rate expectations.However, when connected to the bd port, the flow rate was confirmed to slow down below specifications.The complaint of no flow / cant prime / difficult to prime can be confirmed.Based on what was found the probable cause of flow restriction with the attached bd male luer and chemport lock is unknown as the bd port cannot be fully evaluated as it is a non-icu product.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.
Event or Problem Description
The complaint/event occurred on an unspecified date and involved a chemolock¿ port.The complainant reported that they get sympathetic flow when using a secondary set.The following was encountered: -not pulling, demonstrating some levels of occlusion, when using secondary set that were: -spinning, -non-spinning, -with bonded set cl3511 and-when a cl211 was attached to the smartsite above the pump.There was no report of human harm as a result of this complaint/issue.
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.

• 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: 19387147
• Report Number: 9617594-2024-00647
• Device Sequence Number: 17161583
• Product Code: ONB
• UDI-Device Identifier: 00887709057005
• UDI-Public: (01)00887709057005(17)290101(10)13870344
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2024

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: 13870344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2024
• Supplement Date Received by Manufacturer: 05/24/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 30" APPX 3.6ML, 20 DP ADMIN SET, LISTCL3511, ICU M; UNSPECIFIED IV DISPOSABLE, LIST CL211, MFR UNK; UNSPECIFIED SECONDARY SET (NON-SPINNING), MFR UNK; UNSPECIFIED SECONDARY SET (SPINNING), MFR UNK; UNSPECIFIED SMARTSITE DEVICE OR COMPONENT, MFR UNK
• Patient Sex: Unknown