MAUDE Adverse Event Report: BAXTER HEALTHCARE - LESSINES ACCESS; SET, I.V. FLUID TRANSFER

Catalog Number SDE8076

Device Problem Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that a viaflo port would easily reopen.This occurred before use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).Evaluation summary: the sample was not available for evaluation; however, a sample from the same lot was returned for evaluation.A visual inspection and functional testing were performed.The device was found to securely lock onto the injection site.No malfunctions or abnormalities were identified during the evaluation of the device.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.

• Brand Name: ACCESS
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE - LESSINES; boulevard rene branquart 80; lessines 7860 ; BE 7860
• Manufacturer (Section G): BAXTER HEALTHCARE - LESSINES; boulevard rene branquart 80; lessines 7860 ; BE 7860
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 4056351
• MDR Text Key: 4807279
• Report Number: 1416980-2014-29414
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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
• Report Date: 08/11/2014

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 Catalogue Number: SDE8076
• Device Lot Number: 14A17A50
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2014
• Initial Date FDA Received: 09/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1