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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - MALTA ACCESS; SET, ADMINISTRATION, INTRAVASCULAR

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BAXTER HEALTHCARE - MALTA ACCESS; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number EMC9618
Device Problem Air Leak (1008)
Patient Problem No Patient Involvement (2645)
Event Date 12/04/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that there was air in the line of a solution administration set.This occurred during priming with intravenous immunoglobulin.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
(b)(4).The device was returned and an evaluation is complete.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.The reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
ACCESS
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 Key5384176
MDR Text Key36713419
Report Number1416980-2016-01621
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 02/19/2016
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 No Information
Device Expiration Date01/31/2020
Device Catalogue NumberEMC9618
Device Lot Number15B28V631
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/28/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/08/2016
Initial Date FDA Received01/21/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/19/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/18/2015
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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