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

Catalog Number FMC9673

Device Problem Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Date 08/11/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection revealed sealed tubing underneath the y-site.The cause of the condition was determined to be a manufacturing issue during packaging of the set.To correct this condition, sensors were installed on the packaging machine and awareness training was provided to appropriate personnel.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.

Event Description

It was reported that the tubing of a blood administration pump set was flattened.The flattened tubing was near the y-injection site.This was noted before patient use.There was no patient involvement.No additional information is available.

• 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: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5022053
• MDR Text Key: 23733326
• Report Number: 1416980-2015-33339
• Device Sequence Number: 1
• Product Code: BRZ
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Report Date: 08/13/2015

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: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: FMC9673
• Device Lot Number: 14K06V615
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/21/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/22/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1