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	CL2100T
Medical Device Problem Code	Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2023
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 event occurred on an unspecified date and involved a chemolock¿ port where it was reported that the product is pulling from the primary bag and secondary bag at the same time.The event occurred on during infusion.The product has been used before the issue was noticed and there was no leaking.There was patient involved, and unknown patient harm, but the issue resulted into prolonged infusion time and there was delay in therapy.
Additional Manufacturer Narrative
One video was shared by the customer where an unknown extension set and a chemolock are connected into a bd alaris pump.On the set-up, is observed how drops of solution fall into the drip chamber.However, no slow flow issues or anomalies on the video are observed.Complaint of unintended concurrent flow cannot be confirmed based on the video shared by the customer.The chemolock itself is not responsible for the events described on the complaint.The chemolock icu medical device, works as a connector not as a flow control regulator.The device historoy review (dhr) lot#5598605 was reviewed and no nonconformities were found that would have led the reported condition on the complaint.

• 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: 18026873
• Report Number: 9617594-2023-00892
• Device Sequence Number: 7615355
• Product Code: ONB
• UDI-Device Identifier: 00887709099296
• UDI-Public: (01)00887709099296(17)260901(10)5598605
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 12/08/2023

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 Expiration Date: 09/01/2026
• Device Catalogue Number: CL2100T
• Device Lot Number: 5598605
• 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: 10/04/2023
• Supplement Date Received by Manufacturer: 11/10/2023
• Initial Report FDA Received Date: 10/29/2023
• Supplement Report FDA Received Date: 12/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2021
• 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 PRIMARY BAG, UNK MFR; UNSPECIFIED SECONDARY BAG, UNK MFR
• Patient Sex: Unknown