MAUDE Adverse Event Report: BAXTER HEALTHCARE ¿ ROUND LAKE 3000 ML TPN BAG SET, I.V. FLUID TRANSFER

Catalog Number H938741

Device Problems Cap (424); Loose or Intermittent Connection (1371)

Patient Problem No Patient Involvement (2645)

Event Type  Malfunction  

Manufacturer Narrative

(b)(6) the lot number was manufactured between august 02, 2017 - august 05, 2017. A companion sample was received for evaluation. Visual inspection on the returned sample revealed that the spike port cap was detached from the spike port. No functional testing was performed as during initial inspection the reported condition was verified. The cause of the condition was not 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.

Event Description

During sample evaluation, a spike port cap was detached from the spike port of a 3000 ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag. There was no patient involvement. No additional information is available.

• Brand Name: 3000 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; 125212 w. illinois route 120; round lake IL 60073
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8303316
• MDR Text Key: 134974839
• Report Number: 1416980-2019-00577
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (Y/N): N
• Reporter Country Code: NZ
• PMA/PMN Number: K900585
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE

Reporter Occupation

• Type of Report: Initial
• Report Date: 02/04/2019

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 02/04/2019
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: OTHER
• Device Catalogue Number: H938741
• Device LOT Number: 60078408
• Was Device Available For Evaluation?: No

Is The Reporter A Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/10/2019
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage