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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION INFUSOR; PUMP, INFUSION, ELASTOMERIC
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BAXTER HEALTHCARE CORPORATION INFUSOR; PUMP, INFUSION, ELASTOMERIC Back to Search Results
Catalog Number J2C1009
Device Problem Scratched Material (3020)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/02/2022
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 there were four (4) "scratches" on the tubing line of a large volume infusor.This issue was discovered during filling.There was no patient involvement.No additional information is available.
 
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 there were four (4) "scratches" on the tubing line of a large volume infusor.This issue was discovered during filling.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
The lot was manufactured from august 20, 2021 - august 21, 2021.H10: the device was received for evaluation.Visual inspection was performed using the naked eye which observed tiny minor scratches on the outer surface of the tubing.Leak testing was performed, and no evidence of leak was observed at the scratches on the tubing.The scratches were cosmetic condition as they have no functional impact on the product.The reported condition was verified.The cause of the condition could not be determined.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
PUMP, INFUSION, ELASTOMERIC
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - IRVINE
17511 armstrong avenue
building 3
irvine CA 92614
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 
2242702068
MDR Report Key13600745
MDR Text Key286171846
Report Number1416980-2022-00744
Device Sequence Number1
Product Code MEB
UDI-Device Identifier00085412083193
UDI-Public(01)00085412083193
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 03/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberJ2C1009
Device Lot Number21H053
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/16/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/06/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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