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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE - MALTA 250 EVA BAG SET, I.V. FLUID TRANSFER Back to Search Results
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.

 
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Brand Name250 EVA BAG
Type of DeviceSET, 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 Key8555170
MDR Text Key144563441
Report Number1416980-2019-02305
Device Sequence Number1
Product Code LHI
Combination Product (Y/N)N
Number of Events Reported1
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 Received04/26/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device Catalogue NumberE3MC3801A
Device LOT Number18J03V149
Was Device Available For Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/31/2019
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

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