MAUDE Adverse Event Report: BAXTER HEALTHCARE ¿ ROUND LAKE 500 ML TPN BAG; SET, I.V. FLUID TRANSFER

Catalog Number H938738

Device Problems Fluid/Blood Leak (1250); Misassembled (1398)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The device was manufactured between september 20, 2018 - september 21, 2018.The device was received for evaluation.A visual inspection was performed which observed a arrow marked above the fill port tubing which revealed the top of the fill port tubing sticking outside in front of the bag.There was evidence (moisture) of the bag being used.The cause of the condition was due to the manufacturing process.This issue is being further investigated.A batch review was conducted and there were no deviations found related to this condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

During sample evaluation of a returned 500ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag, the fill port tubing was found sticking outside in front of the bag.There was evidence (moisture) of the bag being used.There was no patient involvement.No additional information is available.

• Brand Name: 500 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: 8803348
• MDR Text Key: 151471807
• Report Number: 1416980-2019-03854
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412477237
• UDI-Public: (01)00085412477237
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: H938738
• Device Lot Number: 60149811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2019
• 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