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

Catalog Number MMC9684

Device Problems Partial Blockage (1065); Melted (1385); Failure to Prime (1492)

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

Event Date 01/29/2014

Event Type  malfunction  

Event Description

It was reported that the customer was unable to prime a blood administration set.The plastic was melted after the filter and blocked the tubing.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: actual sample was not available for evaluation; however, a photo was available.The reported condition was unable to be confirmed with visual inspection of the photograph.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: 3655531
• MDR Text Key: 4196553
• Report Number: 1416980-2014-07238
• 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: 02/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/29/2016
• Device Catalogue Number: MMC9684
• Device Lot Number: 13C31V862
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/06/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/22/2013
• 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