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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
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BAXTER HEALTHCARE CORPORATION; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE Back to Search Results
Catalog Number ASKU
Device Problem Noise, Audible (3273)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/14/2023
Event Type  malfunction  
Manufacturer Narrative
E1: initial reporter first name.E1: initial reporter last name.E1: initial reporter facility name: 00020000-0.E1: initial reporter address: (b)(6).E1: initial reporter city.E1: initial reporter postal code: (b)(6).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 there was an abnormal noise when a minicap transfer set was locked with a solution bag.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
NI
Type of Device
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - MOUNTAIN HOME
1900 n highway 201
mountain home AR 72653
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key16947795
MDR Text Key315412187
Report Number1416980-2023-02407
Device Sequence Number1
Product Code KDJ
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Nurse
Type of Report Initial
Report Date 05/17/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2023
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
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/18/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
DIANEAL
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