MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. MICROCLAVE¿ CLEAR CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	011-MC100
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: lot number has been updated as plots as 2 possible lot numbers are provided.Lot number: 14321133 with start date 13mar2025 and expiry date is 01feb2030.14292925 with start date 24feb2025 and expiry date is 01feb2030.One device was returned for investigation.It was reported that two (2) photos were provided showing leakage residuals on the black material of the pump carrier and leakage residuals from the microclave to female luer of the mating device connection.The reported complaint can be confirmed.The probable cause is unknown.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.
Event or Problem Description
An event occurred involving a microclave¿ clear connector where the customer reported that after home treatment with a patient receiving chemotherapy drug 5-fluorouracil (5-fu) and the cadd vip infusion pump, the patient returned with leakage observed between the connection of the extension of the 100 ml cassette and the microclave, which was placed on the luer lock connection to seal the cassette.Additionally, it was noted that 5-fu had solidified in the transport bag and at the connection between the microclave and the cassette extension.There was patient involvement, and no delay in therapy; harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
Two (2) photos were provided showing leakage residuals on the black material of the pump carrier and leakage residuals from the microclave to female luer of the mating device connection.The reported complaint can be confirmed.The probable cause is unknown.Without the return of the used sample, a comprehensive failure investigation cannot be performed and a cause cannot be determined.The device history review (dhr) for the possible lot numbers were reviewed and no nonconformities were found that would have led to the reported complaint.

• Brand Name: MICROCLAVE¿ CLEAR CONNECTOR
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 24598408
• Report Number: 9617594-2026-00266
• Device Sequence Number: 8568527
• Product Code: FPA
• UDI-Device Identifier: 00840619042509
• UDI-Public: 00840619042509
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K970855
• 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,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2026

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: 011-MC100
• Device Lot Number: PLOTS
• 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: 02/18/2026
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 100 ML CASSETTE.; 5-FLUOROURACIL.; CADD VIP INFUSION PUMP.; EXTENSION.; LUER LOCK.
• Patient Sex: Unknown