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

Catalog Number	MC100
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for evaluation; however, photos and lot number were provided.Investigation is pending.
Event or Problem Description
The event involved a microclave® clear neutral connector where it was reported the registered nurse (rn) opened the needleless connector and found it had several small black specs inside of the item.There was no patient harm.
Additional Manufacturer Narrative
2 photos were shared by customer, where a several black spots at the purple body's microclave, outside the fluid path is observed, additionally the lot and item information are also shown, no additional damage or anomalies are noted.Complaint of particulate matter on item mc100 can be confirmed based on the photos shared by customer.However, without the return of the used sample, a comprehensive failure investigation cannot be performed, and probable cause cannot be determined.The device history report (dhr) lot# was reviewed, and no non-conformities were found that would have led to the reported condition on the complaint.

• Brand Name: MICROCLAVE® CLEAR NEUTRAL 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: 24073380
• Report Number: 9617594-2026-00024
• Device Sequence Number: 9387432
• Product Code: FPA
• UDI-Device Identifier: 00887709037151
• UDI-Public: (01)00887709037151(17)300901(10)14595465
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K100434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2026

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: MC100
• Device Lot Number: 14595465
• 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: 01/06/2026
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/06/2025
• 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
• Patient Sex: Unknown