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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 Problems Unsealed Device Packaging (1444); Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/19/2020
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a minicap had a damaged package; further described as "individual pouch opened".This was observed during use for peritoneal dialysis therapy.There was no patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
Additional information in h3, h4, h6.H10: the actual device was not available; however, photographs were received for evaluation.Visual inspection of the photographs observed that the packaging was opened and a part of the packaging seal was detached.The reported condition was verified.The cause of the condition could not be determined by the photographs.As a result, fourteen (14) retention samples were examined.Upon visual inspection of the retention samples, no open or poorly sealed packages were identified.No deviations were identified that could contribute to the reported condition.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 Key10405336
MDR Text Key202865204
Report Number1416980-2020-04961
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 09/15/2020
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 Date04/30/2022
Device Catalogue NumberABC4466BA
Device Lot NumberM20E12A
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/21/2020
Initial Date FDA Received08/13/2020
Supplement Dates Manufacturer Received09/07/2020
Supplement Dates FDA Received09/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
DIANEAL SOLUTION
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