MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 126" 10 DROP PRIMARY SET W/3 MICROCLAVE®, 2 GANG 4-WAY STOPCOCKS, ROTATING LUER,; STOPCOCK, I.V. SET

Catalog Number	Z3239
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.
Event or Problem Description
The incident involved a 126" 10 drop primary set w/3 microclave¿, 2 gang 4-way stopcocks, rotating luer, 1 ext.A medsun medwatch mandatory report uf/importer report # (b)(4) was received by the manufacturer.Per the report, nursing noted that the anesthesia tubing would not allow intravenous fluids (ivf) to flow.The bottom luer-lock port was not flushable.The peripheral iv (piv) itself was patent.There was no reported patient harm and only ivf noted to be running, not anesthetic medication.The original intended procedure was for iv tubing to deliver ivf and anesthetic once patient was in the operating room.There were no observed damages or anomalies with the set and/or the mating /access devices.There was patient involvement and no harm reported.

• Brand Name: 126" 10 DROP PRIMARY SET W/3 MICROCLAVE®, 2 GANG 4-WAY STOPCOCKS, ROTATING 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: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18074220
• Report Number: 9617594-2023-00943
• Device Sequence Number: 15370142
• Product Code: FMG
• UDI-Device Identifier: 00887709030473
• UDI-Public: (01)00887709030473(17)270601(10)6038095
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/17/2023

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 Catalogue Number: Z3239
• Device Lot Number: 6038095
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2023
• Initial Report FDA Received Date: 11/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2022
• 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: UNSPECIFIED IV FLUIDS, MFR UNK
• Patient Sex: Unknown