MAUDE Adverse Event Report: BAXTER HEALTHCARE ¿ ROUND LAKE 250 ML TPN BAG; SET, I.V. FLUID TRANSFER

Catalog Number H938737

Device Problems Fluid/Blood Leak (1250); Material Perforation (2205)

Patient Problem No Patient Involvement (2645)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a 250ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag had a pin-sized hole in the middle of the bag resulting in leakage.The leak was discovered prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information : the lot number was manufactured between november 03, 2017 - november 04, 2017.The actual device was not available; however, a photograph of the sample was provided for evaluation.The returned photograph showed evidence of a leak coming from the administration port connector.The reported condition was verified.The cause of the reported 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.This issue is being further investigated.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: 250 ML TPN BAG
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE ¿ ROUND LAKE; round lake IL
• Manufacturer (Section G): BAXTER HEALTHCARE ¿ ROUND LAKE; 25212 w. illinois route 120; round lake IL 60073
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8219643
• MDR Text Key: 132199458
• Report Number: 1416980-2018-08199
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412477213
• UDI-Public: (01)00085412477213
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K900585
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/07/2019

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: 10/31/2020
• Device Catalogue Number: H938737
• Device Lot Number: 60095447
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/12/2018
• Initial Date FDA Received: 01/04/2019
• Supplement Dates Manufacturer Received: 01/25/2019
• Supplement Dates FDA Received: 02/07/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1