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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - MALTA ACCESS; SET, BLOOD TRANSFUSION
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BAXTER HEALTHCARE - MALTA ACCESS; SET, BLOOD TRANSFUSION Back to Search Results
Catalog Number EMC0349
Device Problem Failure to Disconnect (2541)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
It was reported that the luer lock connector of a blood administration set was unable to be disconnected.This occurred at the end of a patient transfusion.There was no patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
(b)(4).This issue was reported to have occurred on an unknown date in (b)(6) 2013.The device was not returned; therefore, an evaluation could not be conducted.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
ACCESS
Type of Device
SET, BLOOD TRANSFUSION
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
christina arnt
25212 w. illinois route 120
round lake, IL 60073
2242703198
MDR Report Key3567831
MDR Text Key4215868
Report Number1416980-2014-01198
Device Sequence Number1
Product Code BRZ
Combination Product (y/n)N
Reporter Country CodeSZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Nurse
Type of Report Initial
Report Date 12/16/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberEMC0349
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/16/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
BLOOD
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