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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK CONTINU-FLO MULTI-PORT MANIFOLD; STOPCOCK, I.V. SET
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BAXTER HEALTHCARE CORPORATION CLEARLINK CONTINU-FLO MULTI-PORT MANIFOLD; STOPCOCK, I.V. SET Back to Search Results
Catalog Number 2C8931
Device Problems Crack (1135); Material Twisted/Bent (2981)
Patient Problem No Patient Involvement (2645)
Event Date 09/24/2019
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that "the manifold on either end" of a clearlink system continu-flo solution set was "cracked, bent and not working".This was identified during priming.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
The actual sample was received for evaluation.A visual inspection was performed, and it was noted that port of the manifold was bent and almost broken.The reported problem was verified during initial inspection.The cause of the condition was due to a manufacturing issue.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
CLEARLINK CONTINU-FLO MULTI-PORT MANIFOLD
Type of Device
STOPCOCK, I.V. SET
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key9305882
MDR Text Key166324925
Report Number1416980-2019-06235
Device Sequence Number1
Product Code FMG
UDI-Device Identifier00085412071725
UDI-Public(01)00085412071725
Combination Product (y/n)N
PMA/PMN Number
K932512
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 12/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number2C8931
Device Lot NumberDR19D15033
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2019
Date Manufacturer Received12/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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