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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION INFUSOR; BAXTER HEALTHCARE CORPORATION

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BAXTER HEALTHCARE CORPORATION INFUSOR; BAXTER HEALTHCARE CORPORATION Back to Search Results
Catalog Number 2C1702KP
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Date 11/04/2020
Event Type  malfunction  
Manufacturer Narrative
The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that the bladder of a small volume infusor was damaged (broken) during injection/mixing.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
H10: the actual sample was received for evaluation.Visual inspection was performed using the naked eye which revealed that the bladder was ruptured.Microscopic inspection was performed to identify any issues that could have caused the rupture.No signs of abnormality were observed.The reported condition was verified.The cause of the condition was not determined; however, the most likely cause of the condition is manufacturing related.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 Name
INFUSOR
Type of Device
BAXTER HEALTHCARE CORPORATION
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key10951289
MDR Text Key219893898
Report Number1416980-2020-07560
Device Sequence Number1
Product Code MEB
UDI-Device Identifier00085412081441
UDI-Public(01)00085412081441
Combination Product (y/n)Y
PMA/PMN Number
K071222
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/30/2020
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 Health Professional
Device Catalogue Number2C1702KP
Device Lot Number19K037
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2020
Initial Date Manufacturer Received 11/10/2020
Initial Date FDA Received12/05/2020
Supplement Dates Manufacturer Received12/14/2020
Supplement Dates FDA Received12/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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