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

Catalog Number	CL3940
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 - date of event - the date of event is unknown, and 01 jan 2025 has been used as a placeholder.Samples have been received, but the investigation is pending completion.Upon completion a supplemental mdr will be submitted.
Event or Problem Description
A complaint was received regarding a chemolock¿ bag spike with clave¿ additive port that experienced leakage during use.The report stated that they would like to report that they had another incident with chemotherapy leaking from the blue side port of the chemolock bag spike with clave.After 1.5 hours into a 4-hour infusion, mother of patient reported chemotherapy leaking from the blue side port.This caused a lot of concern with patient's family due to safety concern and hazard risk this posed.Nurse only documented event and did not take photos.Chemotherapy preparation discarded in accordance with institution chemo spill guidelines.There was no patient harm noted.
Additional Manufacturer Narrative
Received five new devices for evaluation.As received, no physical damage or other anomalies observed.No mating device was returned.All 5 new returned devices were leak tested, accessed the blue port 5x each while at pressure, and no leaks or stick downs were observed.Without the return of the failed device, unable to confirm the customer complaint of chemotherapy leaking from the blue side port.The lot history review was conducted, and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: CHEMOLOCK¿ BAG SPIKE WITH CLAVE¿ ADDITIVE 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: 21956638
• Report Number: 9617594-2025-00885
• Device Sequence Number: 7227100
• Product Code: ONB
• UDI-Device Identifier: 00887709095298
• UDI-Public: (01)00887709095298(17)300201(10)14303452
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2025

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: CL3940
• Device Lot Number: 14303452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 05/04/2025
• Supplement Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2025
• 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 CHEMO INFUSATE, MFR UNK.
• Patient Sex: Unknown