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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE - MALTA SOLUTION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number MMC9628
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Patient Involvement (2645)
Event Date 06/09/2017
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 the packaging of one (1) vented nitroglycerin set was damaged. The reporter stated that this product had been on the bottom layer of the carton, and that the back packaging film appeared to be pierced. There was no patient involvement. No additional information is available.
 
Manufacturer Narrative
The actual device was not available; however, a photograph of the sample was provided for evaluation. Visual inspection of the photograph showed the packaging was torn. The reported condition was verified. The cause of the event was due to human error. Refresher training sessions have been conducted, on the positioning of the hard components (roller clamp, slide clamp, etc. ) during the coiling method prior the packaging step, to mitigate the risk of such occurrence. 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.
 
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Brand NameSOLUTION 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 Key6682817
MDR Text Key78912593
Report Number1416980-2017-05513
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeAS
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,Followup
Report Date 08/03/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/30/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date10/31/2021
Device Catalogue NumberMMC9628
Device Lot Number16K18T349
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/24/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/29/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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