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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION; DISPENSER, LIQUID MEDICATION
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BAXTER HEALTHCARE CORPORATION; DISPENSER, LIQUID MEDICATION Back to Search Results
Catalog Number ASKU
Device Problem Illegible Information (4050)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that the graduation marks on an unspecified quantity of 5ml exactamed oral syringes were illegible.The syringes had faint blue ink markings which made it difficult to read measurements when drawing up liquids into the syringe.It was not specified if the devices were used for patient therapy.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
Additional information was added to device evaluated by mfr and evaluation codes.The actual device was not available; however, a photograph of the sample was provided for evaluation.A visual inspection was performed to the photograph using the naked eye which did not identify any abnormalities that could have contributed to the reported condition.The reported condition was not verified.No additional testing could be performed due to lack of an actual sample.Therefore, the reported problem could not be verified or refuted.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
NI
Type of Device
DISPENSER, LIQUID MEDICATION
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key9950278
MDR Text Key187272470
Report Number1416980-2020-02127
Device Sequence Number1
Product Code KYX
Combination Product (y/n)N
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberASKU
Device Lot NumberASKU
Was Device Available for Evaluation? No
Date Manufacturer Received06/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NI.
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