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	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for evaluation.The investigation is pending completion.Upon completion a supplemental mdr will be submitted.
Event or Problem Description
A complaint was received regarding microclave clear connector that experienced no flow.The reporter stated the following:¿ the radiopharmaceutical could not be injected via the bidirectional valve.No problems were observed during device insertion.This issue was encountered with several valves from the same batch, which is why we quarantined the valves from that batch.A valve from another batch was then used without incident.There was no consequence for the personnel.¿ there is patient involvement.The event was noticed at the beginning of the injection of the medication.The name of the radiopharmaceutical medication is not known.
Additional Manufacturer Narrative
The complaint could not be confirmed by investigation.No product samples, pictures, or videos were received for investigation.Without the return of the used sample, a comprehensive failure investigation cannot be performed and a cause cannot be determined.The dhr was 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: 23537120
• Report Number: 9617594-2025-02158
• Device Sequence Number: 15959265
• Product Code: FPA
• UDI-Device Identifier: 00840619042509
• UDI-Public: (01)00840619042509(17)300301(10)14346410
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K970855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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: 14346410
• 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: 10/29/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/18/2025
• 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 RADIOPHARMACEUTICAL, MFR UNKNOWN.
• Patient Sex: Unknown