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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 6AC4466
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The event occurred on an unspecified date in (b)(6) 2020.Expiration date: 01/2022.The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that the aluminum foil of thirty-seven (37) minicaps had "air leakage" (lacked good seal).This was observed before use for peritoneal dialysis therapy.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
Thirty-seven (37) samples were received for evaluation.Visual inspection was performed and found the sealings of the samples were not stuck well.The reported condition was verified.The cause of the condition was found to be supplier manufacturing related.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 Key10393068
MDR Text Key202500940
Report Number1416980-2020-04894
Device Sequence Number1
Product Code KDJ
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,foreig
Type of Report Initial,Followup
Report Date 08/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number6AC4466
Device Lot NumberGM2002192
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/20/2020
Date Manufacturer Received08/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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