MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION 4000 ML TPN BAG; SET, I.V. FLUID TRANSFER

Catalog Number H938742

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 10/28/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that twenty-six (26) units of 4000ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bags were leaking coming at the port.The leaks were discovered during setup and preparation.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added to d10, h3, h4, and h6.H10: only three (3) actual samples were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A functional testing was performed with tap water which revealed a leak between the spike port cap tube and the spike port bonding area of all 3 samples.The reported condition was verified for the returned samples.The cause of the condition was not determined; however, the most likely cause was due to inadequate or lack of cyclohexanone applied during the manufacturing process.The remaining twenty-three (23) samples were not received for evaluation; therefore, a device analysis could not be completed for those samples.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: 4000 ML TPN BAG
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10880215
• MDR Text Key: 217968283
• Report Number: 1416980-2020-07287
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412477268
• UDI-Public: (01)00085412477268
• 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: 12/22/2020

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: 08/31/2021
• Device Catalogue Number: H938742
• Device Lot Number: 60148501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2020
• Initial Date Manufacturer Received: 10/28/2020
• Initial Date FDA Received: 11/20/2020
• Supplement Dates Manufacturer Received: 12/09/2020
• Supplement Dates FDA Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1