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

Catalog Number 2C8541

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

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

Event Date 03/31/2014

Event Type  malfunction  

Event Description

It was reported that tubing of a clearlink duo vent continu-flo set was found split under the drip chamber.This occurred while the set was being primed and saline solution had leaked.No additional information is available.

Manufacturer Narrative

(b)(4).Additional information: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Evaluation summary: one sample was available at the plant for evaluation.Visual inspection confirmed cut in the tubing of the sample, about half way through.The reported condition was confirmed.No other test was performed.Initial evaluation confirmed the reported condition.Upon completion of baxter's investigation, a follow-up will be submitted.

Manufacturer Narrative

(b)(4).The cause of the condition was determined to be due to a manufacturing issue.In order to address this condition, a capa was opened.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: ACCESS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE; 600 mts oeste de entrada; cartago ; CS
• Manufacturer (Section G): BAXTER HEALTHCARE; 600 mts oeste de entrada; cartago ; CS
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3774345
• MDR Text Key: 4446384
• Report Number: 1416980-2014-13547
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/31/2014

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: 09/02/2018
• Device Catalogue Number: 2C8541
• Device Lot Number: R13I02143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/29/2014
• Initial Date FDA Received: 04/25/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2013
• 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