MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 110" 15 DROP PRIMARY SET W/2 CLAVE¿ REMV 2 GANG 4-WAY STOPCOCKS,2 CHECK VALVES,; STOPCOCK, I.V. SET

Catalog Number	B90111
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred on an unspecified date and involved a 110" 15 drop primary set w/2 clave¿ remv 2 gang 4-way stopcocks,2 check valves, rotating luer, 1 ext.It was reported that a separation/disconnection occurred as the later part of the stopcock was disconnected during priming for an infusion of lactated ringers.There was no harm reported as a result of this event.
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.E1 initial reporter (full) phone:(b)(6).

• Brand Name: 110" 15 DROP PRIMARY SET W/2 CLAVE¿ REMV 2 GANG 4-WAY STOPCOCKS,2 CHECK VALVES,
• 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: 17389648
• Report Number: 9617594-2023-00433
• Device Sequence Number: 19802157
• Product Code: FMG
• UDI-Device Identifier: 00887709012523
• UDI-Public: (01)00887709012523(17)270701(10)6050629
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 07/20/2023

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: B90111
• Device Lot Number: 6050629
• 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: 07/20/2023
• Initial Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2022
• 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 LACTATED RINGERS, MFR UNK
• Patient Sex: Unknown