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, where it was reported the intravenous (iv) tube is not working properly.The customer stated that they can prime the tubing, but once hooked up to a patient it does not run correctly.Furthermore, if the customer takes the first part of the tubing off at the stopcock, it seems to work, but they need this piece attached.The customer reported that the separation/ disconnection occurs if latter part of stopcock is disconnected.It was reported that tubing has been hooked up to patients and then had to be changed.There was patient involvement, but no report of patient harm.
Additional Manufacturer Narrative
The complaint of defective/malfunctioning components on item b90111 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 review (dhr) for lot 6050629 was reviewed and no non conformities were found that would have led to the reported complaint.

• 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: 17511229
• Report Number: 9617594-2023-00535
• Device Sequence Number: 17526973
• 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): 07/18/2023

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: 07/18/2023
• Initial Report FDA Received Date: 08/11/2023
• 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: LACTATED RINGER'S, UNK MFR
• Patient Sex: Unknown