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

Catalog Number E3MC3801A

Device Problem 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

1 Patient was 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
• Date Manufacturer Received: 03/31/2019
• Type of Device Usage: N
• Patient Sequence Number: 1