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 10/17/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a 250 ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag leaked from a hole at the port.The leakage was discovered during preparation and before patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information : the device was manufactured november 10, 2018 to november 11, 2018.The device was received for evaluation.Functional testing was performed and revealed a leak from the top left corner of the bag.Microscopic inspection was performed and revealed weld defects at the corner.The reported condition of a leaking port was not verified.The cause of the leak at the corner was not determined.This issue is being further investigated.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: 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: 8189602
• MDR Text Key: 131168552
• Report Number: 1416980-2018-07967
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412477213
• UDI-Public: (01)00085412477213
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K900585
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 02/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• 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: 60096703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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