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 Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation.The investigation is pending completion.
Event or Problem Description
A complaint was received regarding a microclave® clear connector that experienced loose connection and leakage.The reporter stated that " the connector does not "grab" the syringe enough and the contents squirt back/pass.¿ the status of the product at the time of the event was during infusion.It was not detected prior to direct patient use.No serious injury/death, no blood loss, no unprotected chemo exposure , no delay in critical therapy , no adverse operator consequences , no med/surg intervention required.The devices were changed out/replaced with no further problems encountered.Involved product was disposed but same lot device sample is available for investigation.Update: providing additional information stating that there was no any defects, tears, or cuts noted on the product.No unprotected chemo exposure and it did not come into contact with the patient or health care provider.The medication involved is parenteral nutrition.
Additional Manufacturer Narrative
Investigation summary.Received five (5) new.List #011-mc100, microclave¿ clear connector; lot #14265555.No visual damages or anomalies were observed.The reported complaint of disconnection could not be confirmed.The returned samples were tested and met product specifications.Without the return of the used sample a probable cause cannot be determined.The lot history was reviewed, and no nonconformities were identified that may have contributed 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: 22430856
• Report Number: 9617594-2025-01418
• Device Sequence Number: 19621078
• Product Code: FPA
• UDI-Device Identifier: 00840619042509
• UDI-Public: (01)00840619042509(17)300101(10)14265555
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2025

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-MC100
• Device Lot Number: 14265555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2025
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2025
• Is the Device Labeled for Single Use? (Y/N): No
• 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: LUER SLIP SYRINGE, MFR UNKNOWN.; TOTAL PARENTERAL NUTRITION (TPN), MFR UNK.
• Patient Sex: Unknown