MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 128" (325 CM) APPX 16.6 ML, 15 DROP PRIMARY SET W/2 MICROCLAVE¿, REMV 2 GANG 4-W; STOPCOCK, I.V. SET

Catalog Number	B90019
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown if the device is available for evaluation.The device has been requested to be returned, however, it has not been received.Without the returned device, a probable cause is unable to be determined.
Event or Problem Description
The event occurred on an unspecified date and involved a 128" (325 cm) appx 16.5 ml, 15 drop primary set w/2 microclave, remv 2 gang 4-way clave stopcock, rotating luer, 2 ext.The customer reported that the 4-way stopcock will not allow the fluid to flow when attached to the intravenous tubing.It was unknown if there was patient involvement, however, harm was not reported as a consequence of this event.

• Brand Name: 128" (325 CM) APPX 16.6 ML, 15 DROP PRIMARY SET W/2 MICROCLAVE¿, REMV 2 GANG 4-W
• 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: 17595633
• Report Number: 9617594-2023-00580
• Device Sequence Number: 17997459
• Product Code: FMG
• UDI-Device Identifier: 00887709011694
• UDI-Public: (01)00887709011694(17)280301(10)13598628
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Report Date (Section B): 07/26/2023

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: B90019
• Device Lot Number: 13598628
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2023
• 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: INTRAVENOUS TUBING, MFR UNK
• Patient Sex: Unknown