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

Catalog Number H938738

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The date of the event was reported as "probably june 29th or so".Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a 500ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag appeared damaged.The damage was further described as the green clip was defective; therefore, the bag was unable to be closed.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H4: the lot was manufactured from august 30, 2019 - september 03, 2019.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.A visual inspection was performed to the photograph, however the reported condition could not be clearly observed via the dark/blurry photograph and due to the nature of the returned sample no additional testing could be performed.Therefore, the reported condition could not be verified or refuted.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: 500 ML TPN BAG
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10485944
• MDR Text Key: 205458551
• Report Number: 1416980-2020-05413
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: H938738
• Device Lot Number: 60204643
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1