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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
Device Problem Illegible Information (4050)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/26/2024
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that an unspecified quantity of syringes had unreadable graduation marks.This issue was further described as, ¿very light shade of blue/teal that is completely unreadable by someone with tested 20-15 vision in both eyes, under a lamp¿.This issue was observed prior to patient use.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
H10: the devices were not returned and the lot number is unknown; therefore, a device analysis could not be completed.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
Manufacturer (Section G)
BAXTER HEALTHCARE CORPORATION
ni
ni
ni
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key18753448
MDR Text Key336303103
Report Number1416980-2024-00688
Device Sequence Number1
Product Code KYX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/28/2024
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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