MAUDE Adverse Event Report: BAXTER HEALTHCARE - SINGAPORE ACCESS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number FNC3121

Device Problems Fluid/Blood Leak (1250); Split (2537)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that the tubing of a clearlink system solution set split down the side.This occurred during priming and resulted in solution leaking to the floor.There was no patient involvement.No additional information is available.

Manufacturer Narrative

(b)(4).A request for the return of the device has been made.A photograph of the device was received.A batch review will be performed.If any relevant information is obtained that is related to the reported event, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).Evaluation summary: the actual device was not returned; however, the received photograph was evaluated.Photographic inspection identified a split on the side of the tubing.The cause was unable to be determined.In order to further investigate this condition, a capa was opened.Should additional relevant information become available, a supplemental report will be submitted.

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.

• Brand Name: ACCESS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - SINGAPORE; 2 woodlands industrial park; singapore 2573 ; SN 2573
• Manufacturer (Section G): BAXTER HEALTHCARE - SINGAPORE; 2 woodlands industrial park; singapore 2573 ; SN 2573
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3819531
• MDR Text Key: 4392970
• Report Number: 1416980-2014-16193
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup,Followup
• Report Date: 04/24/2014

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: Other
• Device Expiration Date: 06/30/2015
• Device Catalogue Number: FNC3121
• Device Lot Number: SR10K18024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2014
• Initial Date FDA Received: 05/19/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/28/2014; 08/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2010
• 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