MAUDE Adverse Event Report: BAXTER HEALTHCARE ¿ ROUND LAKE 2000 ML TPN BAG; SET, I.V. FLUID TRANSFER

Catalog Number H938740

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

Patient Problem No Patient Involvement (2645)

Event Date 04/03/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a 2000ml exactamix, eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag had a pin-sized hole along the seam.This was identified during an unspecified process step.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

Additional information : the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection of the photo revealed a leak from the spike port.The reported condition was verified.The cause of the condition could not be determined.This issue is being further investigated.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: 8218868
• MDR Text Key: 132124855
• Report Number: 1416980-2018-08194
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/20/2019

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: 08/31/2019
• Device Catalogue Number: H938740
• Device Lot Number: 1180624
• 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: 01/09/2019; 02/14/2019
• Supplement Dates FDA Received: 01/30/2019; 02/20/2019
• 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