MAUDE Adverse Event Report: BAXTER HEALTHCARE ¿ ROUND LAKE 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 10/02/2018

Event Type  malfunction  

Manufacturer Narrative

The report was received from medwatch report number: mw5081223.Correction/removal number: 3010291427-09/12/2018-001-r should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a 2000 ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag was observed leaking from the center port at the ridge.The leak was identified during compounding.There was no patient involvement.No additional information is available.

Manufacturer Narrative

A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Medical device: lot # - from 60105444 to asku.Suspect lot was either lot number 60105444 (expiration date 12/31/2020 and udi (b)(4) or 60124662.Lot 60105444 was manufactured between january 14, 2018 and january 17, 2018.Lot 60124662 was manufactured between may 09, 2018 and may 10, 2018.A batch review was conducted for both suspect lots 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 ¿ 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: 8200119
• MDR Text Key: 131545641
• Report Number: 1416980-2018-08027
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412477244
• UDI-Public: (01)00085412477244
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: H938740
• Device Lot Number: 60105444
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: SEE H10
• Patient Sequence Number: 1