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

Catalog Number MMC9684

Device Problems Kinked (1339); Failure to Prime (1492)

Patient Problem No Patient Involvement (2645)

Event Date 05/28/2014

Event Type  malfunction  

Event Description

It was reported that a blood administration set would not prime; it had kinked tubing below the drip chamber and blood could not flow through.There was no patient involvement.Additional information was requested and is not available.

Manufacturer Narrative

(b)(4).The sample was not returned for evaluation, therefore the reported condition could not be verified and the cause could not be identified.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: 3941834
• MDR Text Key: 4599947
• Report Number: 1416980-2014-23024
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/23/2014

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: 06/30/2016
• Device Catalogue Number: MMC9684
• Device Lot Number: 13G05V208
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/23/2014
• Initial Date FDA Received: 07/17/2014
• Date Device Manufactured: 07/26/2013
• 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