MAUDE Adverse Event Report: BAXTER HEALTHCARE - MALTA SOLUTION OR BLOOD ADMIN.SET; SET, BLOOD TRANSFUSION

Catalog Number RMC9622P

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that the tubing of a blood/solution administration set was crushed.This was noted before use.The reporter stated that the tubing was sealed in the edge of the overpouch.There was no patient involvement.No additional information is available.

Manufacturer Narrative

(b)(4).The device was received for evaluation.Visual inspection revealed that the tubing of the set had been sealed and that the set¿s overpouch had missing seal marks.The reported condition was verified.The cause of the condition was determined to be a manufacturing issue.A capa has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: SOLUTION OR BLOOD ADMIN.SET
• 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: 4608945
• MDR Text Key: 5696370
• Report Number: 1416980-2015-11386
• Device Sequence Number: 1
• Product Code: BRZ
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 02/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: RMC9622P
• Device Lot Number: 14K15V582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2014
• 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