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

Catalog Number MMC9609L

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/18/2013

Event Type  Injury  

Event Description

This is a report of a blood leak coincident with a flo-gard blood administration set.The blood leak was observed from a small hole in the tubing below the valve.The volume of blood loss was not reported.There was no patient injury or medical intervention indicated at the time of this report.Additional information was requested, but is not available.

Manufacturer Narrative

(b)(4).As the sample was not returned, a device analysis cannot be completed.A review of all batch record documents for lot number 13f25v915 was performed with no issues noted during the manufacturing process.There were no deviations from standard procedure and no exceptions related to the reported condition were noted.If additional relevant information is received, a supplemental medwatch will be filed.

• 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: 3591441
• MDR Text Key: 4143413
• Report Number: 1416980-2014-02534
• Device Sequence Number: 1
• Product Code: BRZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 12/30/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: MMC9609L
• Device Lot Number: 13F25V915
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/30/2013
• Date Device Manufactured: 07/11/2013
• 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
• Patient Outcome(s): Other