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

Catalog Number H938737

Device Problems Break (1069); Difficult to Open or Close (2921)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).The device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional clamp testing was performed, and it was noted that it was difficult to close the clamp and resulted in a loose piece of the clamp breaking off.The reported condition was verified.The cause of the condition could not be determined; however, the probable cause was a manufacturing issue.A nonconformance has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the clamp of a 250ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag was difficult to close and resulted in a loose piece of the clamp breaking off.This issue was identified during evaluation of a returned 250ml eva tpn bag.There was no patient involvement.No additional information is available.

• Brand Name: 250 ML TPN BAG
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION; see h10; see h10; see h10
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 10909346
• MDR Text Key: 218929731
• Report Number: 1416980-2020-07400
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): Y
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 11/25/2020

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: Lay User/Patient
• Device Catalogue Number: H938737
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2020
• Initial Date FDA Received: 11/26/2020
• 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: Initial
• Patient Sequence Number: 1