MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION BAXTER 2 LITER EMPTY BAGS; EQUIPMENT LABORATORY, GENERAL PURPOSE, LABELLED OR PROMOTED FOR SPECIFIC MEDICAL

Lot Number 60126015

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 10/20/2018

Event Type  malfunction  

Event Description

Our institution discovered that the baxter 2 liter empty bags had a leak from the central port (the bag has 3 ports altogether) after 2 tpns were made prior to it being delivered to the patient.This is the port that nursing may spike prior to administration but pharmacy does not manipulate this port.Therefore, the port should not have leaked prior to the bag being delivered to the patient's area for administration.All of the lot #60126015 for the baxter 2 liter empty bags have been quarantined and the manufacturer will be notified.

• Brand Name: BAXTER 2 LITER EMPTY BAGS
• Type of Device: EQUIPMENT LABORATORY, GENERAL PURPOSE, LABELLED OR PROMOTED FOR SPECIFIC MEDICAL
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 7999446
• MDR Text Key: 125281296
• Report Number: MW5080762
• Device Sequence Number: 1
• Product Code: LXG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 10/22/2018

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: 10/20/2018
• Device Lot Number: 60126015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/23/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1