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

Device Problem Disconnection (1171)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/01/2023

Event Type  malfunction  

Event 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.

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,
• Type of Device: 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
• MDR Text Key: 321172186
• Report Number: 9617594-2023-00535
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709012523
• UDI-Public: (01)00887709012523(17)270701(10)6050629
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: B90111
• Device Lot Number: 6050629
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2023
• Initial Date FDA Received: 08/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: LACTATED RINGER'S, UNK MFR