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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION MINICAP PREP KITS; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

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BAXTER HEALTHCARE CORPORATION MINICAP PREP KITS; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE Back to Search Results
Catalog Number HZC4226BN
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/06/2022
Event Type  malfunction  
Event Description
It was reported that twenty five (25) minicap prep kits ¿did not have the air inside¿ (pouches were open).This was observed prior to use of the device for peritoneal dialysis (pd) therapy.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Manufacturer Narrative
H10: the actual device was not available; however, five (5) photographs of the sample were provided for evaluation.The photographs revealed a cosmetic defect related to the crumple of the blister and pouches that were opened.The reported condition was verified.The cause of the condition could not be determined.A nonconformance has been opened to address this issue.A batch review was conducted and there were no deviations found related to this 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
MINICAP PREP KITS
Type of Device
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - SAO PAULO
av. alfredo egidio de souza
aranha, 100, bloco c
sao paulo 47261 70
BR   4726170
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 
2242702068
MDR Report Key14281466
MDR Text Key290692048
Report Number1416980-2022-02221
Device Sequence Number1
Product Code KDJ
UDI-Device Identifier00085412363042
UDI-Public(01)00085412363042
Combination Product (y/n)N
Reporter Country CodeCI
PMA/PMN Number
NA
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,Followup
Report Date 09/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date10/31/2022
Device Catalogue NumberHZC4226BN
Device Lot NumberPS66A9
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/07/2022
Initial Date FDA Received05/04/2022
Supplement Dates Manufacturer Received09/12/2022
Supplement Dates FDA Received09/16/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexFemale
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