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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CLEARLINK CONTINU-FLO SOLUTION SET; SET, ADMINISTRATION, INTRAVASCULAR
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CLEARLINK CONTINU-FLO SOLUTION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 2H8519
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 08/20/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
 
Event or Problem Description
It was reported that a clearlink system non-dehp continu-flo solution set leaked at the proximal needleless connector.It was stated that approximately 20ml unspecified fluid leaked.This occurred during patient use.There was no patient injury or medical intervention associated with this event.No additional information is available.
 
Additional Manufacturer Narrative
H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
CLEARLINK CONTINU-FLO SOLUTION SET
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
MDR Report Key12464117
Report Number1416980-2021-05633
Device Sequence Number3925009
Product Code FPA
UDI-Device Identifier00085412048451
UDI-Public(01)00085412048451
Combination Product (Y/N)Y
Initial Reporter CountryCA
PMA/510(K) Number
K961225
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date (Section B) 10/20/2021
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
Operator of Device Health Professional
Device Catalogue Number2H8519
Device Lot NumberR21A13014
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 08/20/2021
Supplement Date Received by Manufacturer10/18/2021
Initial Report FDA Received Date09/13/2021
Supplement Report FDA Received Date10/20/2021
Date Device Manufactured01/14/2021
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
NI.
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