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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION FLEXICAP; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
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BAXTER HEALTHCARE CORPORATION FLEXICAP; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE Back to Search Results
Catalog Number 5C4456
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/31/2021
Event Type  malfunction  
Manufacturer Narrative
The device was 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.
 
Event Description
It was reported that the sterile individual packaging of an unspecified quantity of flexicaps were opened.This was observed before use for peritoneal dialysis therapy.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
 
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Brand Name
FLEXICAP
Type of Device
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - SWINFORD
foxford road
swinford
EI  
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 
2242702068
MDR Report Key12378921
MDR Text Key268519939
Report Number1416980-2021-05285
Device Sequence Number1
Product Code KDJ
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K152129
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Other
Type of Report Initial
Report Date 08/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number5C4456
Device Lot NumberASKU
Was Device Available for Evaluation? No
Date Manufacturer Received08/02/2021
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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