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

Device Problem Inaccurate Flow Rate (1249)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/01/2023

Event Type  malfunction  

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 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.

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,
• Type of Device: 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
• MDR Text Key: 316664611
• Report Number: 9617594-2023-00222
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709079564
• UDI-Public: (01)00887709079564(17)261001(10)5633236
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1