MAUDE Adverse Event Report: BAXTER HEALTHCARE (GAMBRO) I.V. BAG; CONTAINER I.V.

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Information (3190)

Event Date 08/30/2017

Event Type  malfunction  

Event Description

Prismasol (baxter) a product for renal crrt, previously was labeled with a sticker that contained lot and expiration dating.This information is now printed directly onto the plastic of the prismasol bag inside of the overwrap.The moisture between the bag and the overwrap causes the lot and expiration to be obscured or removed.It is difficult or impossible to find lot and expiration dating on this product.

• Brand Name: I.V. BAG
• Type of Device: CONTAINER I.V.
• Manufacturer (Section D): BAXTER HEALTHCARE (GAMBRO)
• MDR Report Key: 6839049
• MDR Text Key: 84740798
• Report Number: MW5071908
• Device Sequence Number: 1
• Product Code: KPI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1