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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - MALTA SECONDARY MEDICATION SET; SET, ADMINISTRATION, INTRAVASCULAR
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BAXTER HEALTHCARE - MALTA SECONDARY MEDICATION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number MMC5991
Device Problem Cut In Material (2454)
Patient Problem No Patient Involvement (2645)
Event Date 02/10/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).(b)(6).A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a secondary medication set had a split in the line.This was noted before use.There was no patient involvement.No additional information is available.
 
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Brand Name
SECONDARY MEDICATION SET
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE - MALTA
a47 industrial estate, malta b
marsa
MT 
Manufacturer (Section G)
BAXTER HEALTHCARE - MALTA
a47 industrial estate, malta b
marsa
MT  
Manufacturer Contact
kinga almasan
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key5481575
MDR Text Key39741291
Report Number1416980-2016-04632
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Nurse
Type of Report Initial
Report Date 03/04/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberMMC5991
Device Lot Number15G07V203
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/10/2016
Date Device Manufactured08/14/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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