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

Catalog Number H938738

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Patient Involvement (2645)

Event Date 04/08/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 was damaged.The damage was further described as "rupture next to the green closure".This was identified prior to use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added to h3, h4 and h6.H4: the lot was manufactured from april 22, 2019 - april 23, 2019.H10: the actual device was not available; however, a companion sample was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A functional testing was performed using tap water and no issues were noted.The reported condition was not verified on the companion sample.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: 10017674
• MDR Text Key: 189701456
• Report Number: 1416980-2020-02483
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412477220
• UDI-Public: (01)00085412477220
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 06/08/2020

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: Other
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: H938738
• Device Lot Number: 60181158
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/08/2020
• Initial Date FDA Received: 05/01/2020
• Supplement Dates Manufacturer Received: 06/06/2020
• Supplement Dates FDA Received: 06/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1