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

Model Number	SC9020
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The incident involved a microclave¿ connector.It was reported that the valve remained open after the iv contrast tubing was disconnected from it.Blood rushed out as there was nothing to stop the flow.No patient harm was reported.
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.
Additional Manufacturer Narrative
The two new sc9020 microclave connectors were received on 11-jul-2023 and functionally tested and both met product performance expectations without silicone seal stick down.No mating devices were returned to evaluate with the sc9020 microclave connectors.The complaint was unable to be replicated or confirmed with the new sc9020 microclave connectors.The device history review (dhr) for lot 12699173 was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.

• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17297954
• Report Number: 9617594-2023-00341
• Device Sequence Number: 3784845
• Product Code: FPA
• UDI-Device Identifier: 00887709040373
• UDI-Public: (01)00887709040373(17)271101(10)12699173
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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): 06/27/2023

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 Model Number: SC9020
• Device Catalogue Number: SC9020
• Device Lot Number: 12699173
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2023
• Supplement Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2022
• 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: IV CONTRAST TUBING, UNK MFR
• Patient Sex: Unknown