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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 08/15/2021
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that the packaging of five (5) minicaps were damaged.The damage was further described as ¿an open in the packing¿.This was observed before use of the devices for peritoneal dialysis therapy.There was no patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
H10: the actual devices were not available; however photographs of the samples were provided for evaluation.The photographs were visually inspected which revealed a pattern that had horizontal crushing (crushed aluminum).There were five (5) open packages observed.On the packaging periphery, the characteristic mark of the formed seal between the formable paper and the printed paper was identified.As a result, the reported condition was verified.The cause of the condition was determined to be mishandling during distribution and/or storage.Fourteen (14) retention samples were evaluated.A visual inspection with the naked eye was performed with no issues noted.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
MDR Report Key12447580
MDR Text Key270574085
Report Number1416980-2021-05543
Device Sequence Number1
Product Code KDJ
UDI-Device Identifier00085412353036
UDI-Public(01)00085412353036
Combination Product (y/n)Y
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 10/08/2021
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 Expiration Date05/31/2023
Device Catalogue NumberABC4466BA
Device Lot NumberM21F07A
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/16/2021
Initial Date FDA Received09/09/2021
Supplement Dates Manufacturer Received10/05/2021
Supplement Dates FDA Received10/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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