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

Catalog Number UMC3325

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/18/2013

Event Type  malfunction  

Event Description

It was reported that a solution administration set could not be disconnected from the stopcock.This occurred during infusion.The reporter stated that the nurse attempted to use a tool to disconnect the set, and the tubing separated from the stopcock.There was no patient injury or medical intervention associated with this event.No additional information is available.This is report 1 of 2 involved in this event.

Manufacturer Narrative

(b)(4).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 returned; therefore, an evaluation could not be conducted.Should additional relevant information become available, a supplemental report will be submitted.This is related to (b)(4).

• Brand Name: ACCESS
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): BAXTER HEALTHCARE - MALTA; a47 industrial estate, malta b; marsa ; MT
• Manufacturer (Section G): BAXTER HEALTHCARE - MALTA; a47 industrial estate, malta b; marsa ; MT
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3623377
• MDR Text Key: 20974761
• Report Number: 1416980-2014-04631
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 01/17/2014

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 Expiration Date: 05/31/2018
• Device Catalogue Number: UMC3325
• Device Lot Number: 13F30V804
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2014
• Initial Date FDA Received: 02/11/2014
• Date Device Manufactured: 06/14/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: KOCHER CLAMP