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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 J2C1701
Device Problem Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/19/2021
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 a small volume infusor had a cracked luer lock.This issue was discovered during storage.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
H4: the device was manufactured from november 21, 2018 - november 26, 2018.H10: the actual device was received for evaluation.A visual inspection was performed using the naked eye found a red luer cap (not a baxter product) was attached to the white luer body of the device.A piece of the luer body was observed to have been cracked and fell off the luer body.The reported condition of 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
MDR Report Key12469093
MDR Text Key271318619
Report Number1416980-2021-05696
Device Sequence Number1
Product Code MEB
Combination Product (y/n)Y
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 10/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberJ2C1701
Device Lot Number18M029
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/01/2021
Date Manufacturer Received10/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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