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

Catalog Number	CL2000S-RC
Medical Device Problem Codes	Fluid/Blood Leak (1250); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred on an unspecified date and involved a chemolock¿ w/red cap where the customer reported that the product was attached to a patient when it was noticed that the male and female chemolock adapters came undone and few drops of chemo leaked.The customer reported that when the nurse did an assessment and reattached them, they could easily be pulled back apart, so they were replaced with a new set.There was patient involvement; no harm that was associated with this event.
Additional Manufacturer Narrative
A sister sample and photo sample are available for evaluation, however, investigation is not yet complete.
Additional Manufacturer Narrative
One photo was shared by the customer, where the item and lot information from the item #cl2000s-rc was observed.No damage or anomalies are confirmed.Sixty-six new samples item #cl2000s-rc, were received for evaluation.As received, based on binomeal stages sampling plan, thirty-five (35) samples were connected using a new chemoport, no disconnections or incomplete connections were observed.Each of the sample was torque test activated confirmed met the product specification and the torque residual as well.All the chemolocks present a good shear tab activation and no damage on the splines.The female luer of the chemolocks were confirmed to comply with iso design expectations complaint of leaks cannot be confirmed or replicated.Lot history review was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: CHEMOLOCK® W/RED CAP
• 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: 18581513
• Report Number: 9617594-2024-00056
• Device Sequence Number: 8246552
• Product Code: ONB
• UDI-Device Identifier: 00887709091887
• UDI-Public: (01)00887709091887(17)281001(10)13791587
• 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): 01/30/2024

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: CL2000S-RC
• Device Lot Number: 13791587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2023
• Supplement Date Received by Manufacturer: 01/15/2024
• Initial Report FDA Received Date: 01/25/2024
• Supplement Report FDA Received Date: 01/30/2024
• 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: CHEMOLOCK¿ PORT, ICU MEDICAL, INC.; UNSPECIFIED CHEMOTHERAPY, MFR UNK.
• Patient Sex: Unknown