MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION 2000 ML TPN BAG; SET, I.V. FLUID TRANSFER

Catalog Number H938740

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 09/08/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address: (b)(6).The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a 2000ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag was defective.The defect was further described as a leak coming from the middle port.This issue was identified during setup and preparation prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added to h3, h4 and h6.H4: device manufactured between november 06, 2019 to november 07, 2019.H10: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A functional test was performed which revealed a leak at the spike port bonding area between the spike port tubing and the spike port connector.The reported condition was verified.The cause was not determined, however, a likely cause of inadequate or lack of cyclohexanone being applied to the cap tubing when it was inserted to the spike port during the manufacturing process was noted.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: 2000 ML TPN BAG
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10613765
• MDR Text Key: 209398682
• Report Number: 1416980-2020-06119
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412477244
• UDI-Public: (01)00085412477244
• 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: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: H938740
• Device Lot Number: 60213295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Date Manufacturer Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1