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

Catalog Number H938737

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that an unspecified quantity of 250 ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag were leaking from the middle port.The leaks were discovered during an unspecified process step; however, prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information : the lot was manufactured june 30, 2018 -- july 01, 2018.Two (2) samples were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed and revealed a leak at the spike port cap of both samples.The reported condition was verified.The cause of the condition could not be 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: 8201532
• MDR Text Key: 131584135
• Report Number: 1416980-2018-08047
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412477213
• UDI-Public: (01)00085412477213
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K900585
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2019

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: 05/31/2021
• Device Catalogue Number: H938737
• Device Lot Number: 60132897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/27/2018
• Initial Date FDA Received: 12/27/2018
• Supplement Dates Manufacturer Received: 02/01/2019
• Supplement Dates FDA Received: 02/15/2019
• 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