MAUDE Adverse Event Report: BAXTER HEALTHCARE - MALTA 250 EVA BAG SET, I.V. FLUID TRANSFER

Catalog Number E3MC3801A

Device Problems Cap (424); Material Puncture/Hole (1504)

Patient Problem No Patient Involvement (2645)

Event Type  Malfunction  

Manufacturer Narrative

The actual sample was received for evaluation. The returned unit was labeled for single use. A visual inspection was performed and it was noted that the cap had a hole in it. The reported problem was verified. The cause of the condition was determined to be a manufacturing issue. 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

This report summarizes 1 malfunction events. It was reported that a 250 ml eva bag had a hole in the cap at the top of the bag. This event occurred during preparation. There was no patient involvement. No additional information is available.

• Brand Name: 250 EVA BAG
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE - MALTA; marsa
• Manufacturer (Section G): BAXTER HEALTHCARE - MALTA; a47 industrial estate; marsa ; MT
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8555170
• MDR Text Key: 144563441
• Report Number: 1416980-2019-02305
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (Y/N): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 04/26/2019

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 04/26/2019
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: No
• Device Operator: NO INFORMATION
• Device Catalogue Number: E3MC3801A
• Device LOT Number: 18J03V149
• Was Device Available For Evaluation?: No Answer Provided

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/31/2019
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Is The Device Single Use?: No Answer Provided

Is this a Reprocessed and Reused Single-Use Device?

Type of Device Usage