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

Catalog Number 2C6204

Device Problem Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

This report summarizes 1 malfunction events.It was reported that the stopcock of a large bore stopcock with rotating male luer lock would not thread onto the luer lock.This occurred prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.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 - AIBONITO; aibonito
• MDR Report Key: 8540932
• MDR Text Key: 142954707
• Report Number: 1416980-2019-02185
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 07/29/2019

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?: No
• Device Operator: No Information
• Device Catalogue Number: 2C6204
• Device Lot Number: UR18J23051
• Initial Date Manufacturer Received: 03/31/2019
• Initial Date FDA Received: 04/23/2019
• Supplement Dates Manufacturer Received: 06/30/2019
• Supplement Dates FDA Received: 07/29/2019
• Patient Sequence Number: 1