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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION STOPCOCK; STOPCOCK, I.V. SET
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BAXTER HEALTHCARE CORPORATION STOPCOCK; STOPCOCK, I.V. SET Back to Search Results
Catalog Number 2C6204
Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/04/2021
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that three (3) large bore stopcocks were defective.The defect was further described as packaging were not sterile, air leak from the side of sealed edge.This issue was identified prior to patient use.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
Additional information was added to d9, h3, h4 and h6.H10: three (3) actual samples were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A bubble test was performed on each received sample and no defects or seal damage was identified.The reported condition was not verified.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
STOPCOCK
Type of Device
STOPCOCK, I.V. SET
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key12084978
MDR Text Key258983381
Report Number1416980-2021-03972
Device Sequence Number1
Product Code FMG
UDI-Device Identifier00085412001913
UDI-Public(01)00085412001913
Combination Product (y/n)Y
PMA/PMN Number
K130245
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 08/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number2C6204
Device Lot NumberUR20J16028
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/24/2021
Date Manufacturer Received08/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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