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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION MINIBAG PLUS CONTAINER; SEE H10
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BAXTER HEALTHCARE CORPORATION MINIBAG PLUS CONTAINER; SEE H10 Back to Search Results
Catalog Number 2C4950
Device Problem Corroded (1131)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Common device name: equipment, laboratory, general purpose, labeled or promoted for a specific medical use.(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that three (3) mini-bag plus container/vial docking tools were observed to be damaged.The damage was further reported as ¿rusted gears on the underside of the device;¿ ¿the gears that causes the handles to compress and decompress.¿ the reporter stated that the device was still functional.This issue was identified prior to patient use.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
The devices were not returned and the lot numbers are unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
MINIBAG PLUS CONTAINER
Type of Device
SEE H10
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key9627444
MDR Text Key176256520
Report Number1416980-2019-07647
Device Sequence Number1
Product Code LXG
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 02/21/2020
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 Catalogue Number2C4950
Device Lot NumberASKU
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/30/2019
Initial Date FDA Received01/24/2020
Supplement Dates Manufacturer Received02/09/2020
Supplement Dates FDA Received02/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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