MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 19" (48 CM) EXT SET W/FLOW CONTROLLER, MICROCLAVE® CLEAR, CLAMP, ROTATING LUER,; PRIMARY IV SET

Model Number	MRSFC-19
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for evaluation- it has not been received.E1 - initial reporter phone has an extension number of (b)(6).
Event or Problem Description
The event occurred on an unknown date involving a 19" (48 cm) ext set w/flow controller, microclave¿ clear, clamp, rotating luer, approx priming volume: 2.5 ml where it was reported that the end user claimed the flow rate is ~66% off and the controller does not accurately control the flow rate.The device was used in treatment or patient care.There was patient involvement but no human harm.No additional information was provided.
Additional Manufacturer Narrative
Additional information: d9 - device available for evaluation and h3 - evaluation summary attached the complaint of difficult to control flow rate on item mrsfc-19 could not be confirmed by investigation.Since 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 device history report (dhr) for lot 5633236 was reviewed and no non conformities were found that would have led to the reported complaint.

• Brand Name: 19" (48 CM) EXT SET W/FLOW CONTROLLER, MICROCLAVE® CLEAR, CLAMP, ROTATING LUER,
• Common Device Name: PRIMARY IV SET
• 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: 17035461
• Report Number: 9617594-2023-00222
• Device Sequence Number: 12360807
• Product Code: FMG
• UDI-Device Identifier: 00887709079564
• UDI-Public: (01)00887709079564(17)261001(10)5633236
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K964435
• 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): 05/08/2023

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 Expiration Date: 10/01/2026
• Device Model Number: MRSFC-19
• Device Catalogue Number: MRSFC-19
• Device Lot Number: 5633236
• 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: 05/08/2023
• Supplement Date Received by Manufacturer: 06/07/2023
• Initial Report FDA Received Date: 05/31/2023
• Supplement Report FDA Received Date: 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2021
• 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