MAUDE Adverse Event Report: BAXTER HEALTHCARE - ENGLEWOOD 500 ML TPN BAG; SET, I.V. FLUID TRANSFER

Catalog Number H938738

Device Problems Detachment Of Device Component (1104); Fluid/Blood Leak (1250); Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 02/13/2018

Event Type  malfunction  

Manufacturer Narrative

The device was returned and an evaluation is complete.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Visual inspection was performed and noted the add port cap and spike port cap were detached.Functional leak testing was performed by filling the bag with tap water.A leak was found at the spike port where the cap was detached.The reported issue was verified.The cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

During evaluation of a returned 500ml exactamix eva tpn bag it was found that the spike port cap was detached.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 - ENGLEWOOD; englewood CO
• Manufacturer (Section G): BAXTER HEALTHCARE - ENGLEWOOD; 14445 grasslands dr; englewood CO 80112
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7402924
• MDR Text Key: 104573953
• Report Number: 1416980-2018-01907
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412477220
• UDI-Public: (01)00085412477220
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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
• Type of Report: Initial
• Report Date: 04/06/2018

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: 05/31/2020
• Device Catalogue Number: H938738
• Device Lot Number: 1234177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2018
• Initial Date Manufacturer Received: 03/12/2018
• Initial Date FDA Received: 04/06/2018
• 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