MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION 1000 ML TPN BAG; SET, I.V. FLUID TRANSFER

Catalog Number H938739

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 04/29/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a white foreign material was observed on the fill port cap of 5 1000ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bags.This issue was identified prior to use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added to d4, d10, h3, h4 and h6.H4: the lot was manufactured between june 12, 2019 to june 13, 2019.H10: five (5) actual samples were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.No functional testing was performed on this complaint.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: 1000 ML TPN BAG
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10083145
• MDR Text Key: 191976083
• Report Number: 1416980-2020-02886
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• PMA/PMN Number: K900585
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/21/2020

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 Catalogue Number: H938739
• Device Lot Number: 60189513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2020
• Initial Date Manufacturer Received: 04/29/2020
• Initial Date FDA Received: 05/22/2020
• Supplement Dates Manufacturer Received: 07/16/2020
• Supplement Dates FDA Received: 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1