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

Catalog Number	011-C3300
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation.The investigation is pending completion.
Event or Problem Description
Event occurred regarding a clave neutral connector where they reported leakage with the connector which was connected to a syringe.They listed five possible lots that could have been affected but are not sure of the particular lot.Only one (1) device was reported to be affected.The complaint stated that the leak was noted at the start of aspiration, and it was confirmed that the substance leaking from the product was blood.Normal saline was used as the solution.A crack was observed.There was patient involvement, but no one was harmed.There was no unprotected drug exposure to the patient or healthcare providers.The product was replaced, and therapy resumed without further issues.
Additional Manufacturer Narrative
Investigation summary received one (1) used list# 011-c3300, microclave® connector; lot# unknown --> one (1) used list# unknown,10ml syringe; lot# unknown.The microclave was disconnected from the syringe and found to have a torn seal.The reported complaint of a leak could be confirmed.The photo received showed a blood leak in the microclave.Upon receiving it was observed to have a torn seal.The probable cause of the torn seal and leak is from the use of an incompatible mating device.The dfu states: needlefree connectors are compatible with iso male luers having an internal diameter between 0.062" (1.58 mm) and 0.110" (2.8 mm).The possible lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.
Additional Manufacturer Narrative
The complaint investigation was modified and approved on 26nov2025 as follows: the reported complaint of a leak could be confirmed.The photo received showed a blood leak in the microclave.The microclave was measured and was found to be iso compliant.Upon receiving, it was observed to have a torn seal.The probable cause of the torn seal and leak is from the use of an incompatible mating device.While the returned syringe was compatible, it is unknown if another mating device was used that was incompatible.The dfu states: needle free connectors are compatible with iso male luers having an internal diameter between 0.062" (1.58 mm) and 0.110" (2.8 mm).The possible lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.Corrected information can be found in e4 - initial report sent to fda , h6 component code, h6 investigation findings and h6 investigation conclusions.

• Brand Name: MICROCLAVE® 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: 22739314
• Report Number: 9617594-2025-01641
• Device Sequence Number: 7218508
• Product Code: FPA
• UDI-Device Identifier: 00840619001421
• UDI-Public: 00840619001421
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/08/2025

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: 011-C3300
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2025
• Supplement Date Received by Manufacturer: 09/03/2025; 11/26/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 09/26/2025; 12/08/2025
• 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: NORMAL SALINE (MANUFACTURER UNKNOWN).
• Patient Sex: Unknown