MAUDE Adverse Event Report: BAXTER HEALTHCARE - MALTA IVT DISPOSABLE; CONTAINER, I.V.

Catalog Number E3MC3804

Device Problem Material Separation (1562)

Patient Problem No Patient Involvement (2645)

Event Date 08/01/2014

Event Type  malfunction  

Event Description

It was reported that the closure cap of an eva tpn bag was loose.There was no patient involvement.No additional information is available.

Manufacturer Narrative

(b)(4).Evaluation summary: the actual device was evaluated.Visual inspection of the unit revealed that the vented luer cap was loose in the overpouch.The cause was unable to be determined.The condition was verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.A capa has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: IVT DISPOSABLE
• Type of Device: CONTAINER, I.V.
• 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: 4274937
• MDR Text Key: 5029444
• Report Number: 1416980-2014-42331
• Device Sequence Number: 1
• Product Code: KPE
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 10/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: E3MC3804
• Device Lot Number: 14C01V837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2014
• Date Manufacturer Received: 10/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2014
• 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