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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CLEARLINK SOLUTION SET; SET, ADMINISTRATION, INTRAVASCULAR
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CLEARLINK SOLUTION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 2H8486
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 07/16/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).Should additional relevant information become available, a supplemental report will be submitted.
 
Event or Problem Description
It was reported that the filter of a clearlink system non-dehp solution set was leaking.This was observed during priming with lipids.There was no patient involvement.No additional information is available.
 
Additional Manufacturer Narrative
Additional information was added to h3, h4, h6 and h10.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.  visual inspection was performed to the photograph using the naked eye and a leak was observed in the filter.The reported condition was verified.  by the nature of the sample, no additional tests were performed. the cause of the condition could not be determined.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 SOLUTION SET
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
MDR Report Key12344470
Report Number1416980-2021-05126
Device Sequence Number19862446
Product Code FPA
UDI-Device Identifier00085412074764
UDI-Public(01)00085412074764
Combination Product (Y/N)Y
Initial Reporter CountryCA
PMA/510(K) Number
K952074
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) 09/23/2021
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 Number2H8486
Device Lot NumberR21A20118
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 07/28/2021
Supplement Date Received by Manufacturer09/15/2021
Initial Report FDA Received Date08/19/2021
Supplement Report FDA Received Date09/23/2021
Was Device Evaluated by Manufacturer? (Y/N) No
Date Device Manufactured01/21/2021
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
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