MAUDE Adverse Event Report: BAXTER HEALTHCARE - DOMINICAN REPUBLIC STOPCOCK; STOPCOCK, I.V. SET

Catalog Number 2C6218

Device Problem Crack (1135)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 08/01/2016

Event Type  Injury  

Manufacturer Narrative

Medwatch report #(b)(6).(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

A patient experienced a drop in blood pressure while using a three gang large bore stopcock manifold.It was reported that the device cracked and separated during patient's assisted movements, while a vasopressor, norepinephrine, and diluadid were infusing.As a result the patient's blood pressure dropped due to the interruption in infusion.The iv infusion was reconnected and the patient was not harmed as a result of the event.No additional information is available.

Manufacturer Narrative

Medwatch report #(b)(4).The device was received for evaluation.Visual inspection showed one of the stopcock male luer shafts broke off inside the female luer.The reported condition was verified.The cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: STOPCOCK
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): BAXTER HEALTHCARE - DOMINICAN REPUBLIC
• Manufacturer (Section G): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; carretera sanchez km 18.5; haina san cristobal ; DR
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5973198
• MDR Text Key: 55466453
• Report Number: 1416980-2016-15553
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130245
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2C6218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: DILUADID; NOREPINEPHRINE; VASOPRESSOR
• Patient Outcome(s): Other