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

Catalog Number H938738

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problem No Patient Involvement (2645)

Event Date 01/26/2021

Event Type  malfunction  

Manufacturer Narrative

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 defective.The defect was further described as leak coming from ¿a puncture hole in the middle of the primary sheeting towards the top of the bag¿.This issue was identified after filling and during transportation, prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added to d4 (lot#), (expiration date), (udi#), d9, h3, h4, and h6.D4: lot #: the lot # is ¿60210023¿, previously submitted as ¿asku¿.D4: expiration date: the expiration date is ¿09/30/2022¿, previously submitted as ¿ni¿.D4: udi #: (b)(4), previously submitted as ¿ni¿.H4: the lot was manufactured from october 11, 2019 ¿ october 15, 2019.H10: the device was received for evaluation.Unaided visual inspection was performed did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed which revealed a leak only on the left side, approximately at the 400 ml area in back of the bag.Additional magnified inspection was performed which verified a tear/hole where the leak occurred.The reported condition was verified.The cause of the condition could not be determined.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: 11340128
• MDR Text Key: 232381094
• Report Number: 1416980-2021-00712
• Device Sequence Number: 1
• Product Code: LHI
• 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: 03/22/2021

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: 09/30/2022
• Device Catalogue Number: H938738
• Device Lot Number: 60210023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Initial Date Manufacturer Received: 01/26/2021
• Initial Date FDA Received: 02/17/2021
• Supplement Dates Manufacturer Received: 03/09/2021
• Supplement Dates FDA Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1