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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - MALTA SOLUTION SETS SET, ADMINISTRATION, INTRAVASCULAR

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BAXTER HEALTHCARE - MALTA SOLUTION SETS SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number EMC9618
Device Problems Fluid Leak (1250); Cut In Material (2454)
Patient Problem No Patient Involvement (2645)
Event Date 02/22/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). (b)(6). The device was received for evaluation. Visual inspection revealed that the set was sealed partially by the packaging. Underwater pressure testing identified a leak at the location where the set was sealed by the packaging machine. The reported condition was verified. The cause was determined to be due to 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
It was reported that a flogard iv solution set was leaking from a slit in the tubing. This occurred during priming with normal saline. There was no patient involvement. No additional information is available.
 
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Brand NameSOLUTION SETS
Type of DeviceSET, 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 Key5555705
MDR Text Key42153189
Report Number1416980-2016-06772
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeSN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 04/07/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/07/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2020
Device Catalogue NumberEMC9618
Device Lot Number15F11V827
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/29/2016
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/18/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/23/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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