MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION BAXTER LNTRAVIA BAGS; CONTAINER, I.V.

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Description

On three occasions over the last year the septum where you add drugs on the baxter lntravia bags has pulled out when the needle was removed.All of these occurred while doing media-fill testing.The septum itself looks very oxidated and there are no expiration dates on the bags.I actually disposed of all bags and ordered a new case but the septums still looked bad.I haven't had any media-fill tests fail so i guess it is staying sterile, but it is concerning.The specific size bags were 150 ml but the septum of the other sizes look oxidized as well.(b)(4).

• Brand Name: BAXTER LNTRAVIA BAGS
• Type of Device: CONTAINER, I.V.
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 13887581
• MDR Text Key: 288108856
• Report Number: MW5108488
• Device Sequence Number: 1
• Product Code: KPE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1