MAUDE Adverse Event Report: BAXTER HEALTHCARE ¿ ROUND LAKE 1000 ML TPN BAG; SET, I.V. FLUID TRANSFER

Catalog Number H938739

Device Problems Disconnection (1171); Misassembled (1398)

Patient Problem No Patient Involvement (2645)

Event Date 07/17/2018

Event Type  malfunction  

Manufacturer Narrative

The customer reported this event to the fda through medwatch (a copy of the medwatch form or corresponding number were not provided).Device manufactured between: may 24, 2018 - may 25, 2018.The device was received for evaluation.A visual inspection was performed which revealed the top end of the fill port tubing was detached from the inside of the bag and protruding outside the back of the bag.Additionally, the cap was observed missing from the administration port.The reported condition was verified.The cause of the condition could not be determined.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.

Event Description

It was reported that a 1000ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag in which it was observed that the right port was assembled incorrectly on the bag.The entire port was exposed and the bag was sealed leaving the port exposed.The customer stated that this was identified after the bag had been filled.There was not patient involvement.No additional information is available.

• Brand Name: 1000 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: 8327419
• MDR Text Key: 136007326
• Report Number: 1416980-2019-00728
• Device Sequence Number: 1
• Product Code: LHI
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: H938739
• Device Lot Number: 60126009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2019
• Date Manufacturer Received: 01/15/2019
• 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