MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION 500 ML TPN BAG; SET, I.V. FLUID TRANSFER

Catalog Number H938738

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that particulates were observed in an unspecified number of 500ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bags.This was identified in multiple bags after being filled, prior to use on patients.It was further reported that some of the particulates "were obvious scrapings from the ports".The customer reported they used only 18 gauge needles to reconstitute, withdraw, and push into the bags.Some of the bags were filled with methylprednisolone 2.5; others with antibiotics: cefepime, cetriaxone, meropenem, cefazolin, ampicillin, and unasyn (the exact quantities of each were unspecified).It was stated that this was identified ¿after the 7pm fill¿ and when the bags were stored in the refrigerator.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H4: device manufactured between july 23, 2020 to july 24, 2020.H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: 500 ML TPN BAG
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11097728
• MDR Text Key: 224535714
• Report Number: 1416980-2020-08224
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412477220
• UDI-Public: (01)00085412477220
• Combination Product (y/n): Y
• PMA/PMN Number: K900585
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: H938738
• Device Lot Number: 60250619
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1