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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE - MALTA SOLUTION ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number FMC9650
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The actual device was not available; however, a photograph of the sample was provided for evaluation. The photo underwent visual inspection, and a tear was noted in the packaging. The reported problem was verified. The cause of the condition was determined to be during shipment/transportation and also storage of pouches before use. 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 there was a hole in the packaging of solution administration set. This was identified prior to use. There was no patient involvement. No additional information is available.
 
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Brand NameSOLUTION ADMINISTRATION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE - MALTA
marsa
Manufacturer (Section G)
BAXTER HEALTHCARE - MALTA
a47 industrial estate
marsa
MT
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key8021769
MDR Text Key125637700
Report Number1416980-2018-06968
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeTH
PMA/PMN Number
NA
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 10/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberFMC9650
Device Lot Number18A31V144
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/23/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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