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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION MINICAP; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE Back to Search Results
Catalog Number ABC4466BA
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/04/2023
Event Type  malfunction  
Event Description
It was reported that the individual packaging (overpouch) of an unspecified quantity of minicaps were damaged.It was further described as the caps "do not have the bubble in the packaging, the packaging was crushed and it comes off easily, the caps are opened packaging".This was observed before use of the devices for peritoneal dialysis 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: twenty-six (26) actual samples were received for evaluation.A visual inspection with the naked eye identified roughness and in some cases flattened aluminum foil.Nineteen (19) samples were found opened on the sides of the aluminum foil and seven (7) samples were found closed.The samples have aluminum roughness, which indicates a manipulation of the samples potentially during preparation of the therapy.The reported condition was verified.The cause of the condition could not be determined; however, a potential cause is user related.Fourteen (14) retention samples were also evaluated.A visual inspection was performed with no issues noted; the units were without damage, cuts or wrinkles that could affect their operation.In addition, no openings were identified on the sides of the units.The reported condition was not verified on the retention samples.A batch review was conducted and there were no deviations found related to this reported 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
Type of Device
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - CUERNAVACA
ave. de los 50 metros no. 2
cuernavaca 62578
MX   62578
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key16787177
MDR Text Key313862048
Report Number1416980-2023-01910
Device Sequence Number1
Product Code KDJ
UDI-Device Identifier00085412353036
UDI-Public(01)00085412353036
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 05/24/2023
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 Lay User/Patient
Device Catalogue NumberABC4466BA
Device Lot NumberM23A14B
Was Device Available for Evaluation? Device Returned to Manufacturer
Initial Date Manufacturer Received 03/27/2023
Initial Date FDA Received04/21/2023
Supplement Dates Manufacturer Received05/22/2023
Supplement Dates FDA Received05/24/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/17/2023
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
NI.
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