MAUDE Adverse Event Report: BAXTER HEALTHCARE - AIBONITO ACCESS; FILTER, INFUSION LINE

Catalog Number 2N3333

Device Problems Hole In Material (1293); Leak/Splash (1354)

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

Event Date 05/23/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was not returned; therefore, an evaluation could not be conducted.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).Should additional relevant information become available, a follow-up mdr will be submitted.

Event Description

It was reported that a t-connector extension set leaked from a small hole in the back of the filter.This occurred during infusion of an unknown solution.There was no patient injury, medical intervention or adverse event associated with this event.No additional information is available.

• Brand Name: ACCESS
• Type of Device: FILTER, INFUSION LINE
• Manufacturer (Section D): BAXTER HEALTHCARE - AIBONITO; rd 721 km 0 3; po box 1389; aibonito PR 705
• Manufacturer (Section G): BAXTER HEALTHCARE - AIBONITO; rd 721 km 0 3; po box 1389; aibonito PR 705
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3994925
• MDR Text Key: 12640534
• Report Number: 1416980-2014-25782
• Device Sequence Number: 1
• Product Code: FPB
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K113227
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/13/2018
• Device Catalogue Number: 2N3333
• Device Lot Number: UR13B13061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2013
• 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