MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 107" (272CM) APPX 8.7 ML, TRANSF SET W/DUAL CHK VALVE, MICROCLAVE® CLR, ROT LUER; STOPCOCK, I.V. SET

Model Number	MC33892
Medical Device Problem Code	Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 107" (272 cm) appx 8.7 ml, transfer set w/dual check valve, microclave® clear, rotating luer.A medsun mandatory and voluntary medwatch report form ((b)(4)) was received that stated that the "closed medication administration infusion set being utilized on unit for medication administration with flush to follow for infusion via central lines." the medwatch report further states that "normal saline bag attached to set, intended to allow for flush fluid to be pulled into syringe via one way valve has inadvertently infused into the patient.Volume of 90-180ml additional administered over several hours that was not intended." the customer further clarified that the reported event occurred in the hospital.Although there was patient involvement, there was no medical intervention required and no human harm.This captures the second of two events reported.
Additional Manufacturer Narrative
Although the device was requested to be returned for evaluation, it has not been received.Additional contact names/information at the user facility were provided as follows: (b)(6).Uf/importer report# (b)(4).
Additional Manufacturer Narrative
No product samples, videos, or photographs were returned for investigation.The device history record (dhr) was reviewed and there were no relevant non-conformances identified that would have contributed to the reported complaint.The complaint cannot be confirmed based on the information that has been provided.

• Brand Name: 107" (272CM) APPX 8.7 ML, TRANSF SET W/DUAL CHK VALVE, MICROCLAVE® CLR, ROT LUER
• Common Device Name: STOPCOCK, I.V. 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: 14047609
• Report Number: 9617594-2022-00076
• Device Sequence Number: 4884856
• Product Code: FMG
• UDI-Device Identifier: 00887709070790
• UDI-Public: (01)00887709070790(17)261101(10)5711361
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2022

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: MC33892
• Device Catalogue Number: MC33892
• Device Lot Number: 5711361
• 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: 03/10/2022
• Supplement Date Received by Manufacturer: 04/23/2022
• Initial Report FDA Received Date: 04/07/2022
• Supplement Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2022
• 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: NORMAL SALINE, MFR UNK; UNSPECIFIED SYRINGE, MFR UNK
• Patient Age: 17 MO
• Patient Sex: Male
• Patient Weight: 10 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White