MAUDE Adverse Event Report: BAXTER HEALTHCARE - MALTA ACCESS; SET, BLOOD TRANSFUSION

Catalog Number VMC9609

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 08/22/2014

Event Type  malfunction  

Event Description

It was reported that a flo-gard compatible blood set had leaked through the spike.This was noted during priming.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Complaint no: cmplnt-(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.

• Brand Name: ACCESS
• Type of Device: SET, BLOOD TRANSFUSION
• 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: 4163788
• MDR Text Key: 15112136
• Report Number: 1416980-2014-35339
• Device Sequence Number: 1
• Product Code: BRZ
• Combination Product (y/n): N
• Reporter Country Code: SF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/16/2014

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: 05/31/2018
• Device Catalogue Number: VMC9609
• Device Lot Number: 13F27V796
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/16/2014
• Initial Date FDA Received: 10/10/2014
• Date Device Manufactured: 07/05/2013
• 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