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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 2H8603
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 08/04/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Initial reporter address: (b)(6).Device manufacturer address 1: (b)(6).The device has been received and the evaluation is in progress.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 extension set leaked close to one of the sealed areas.The issue was identified during priming while using a 20% unspecified intralipid.There was no patient involvement.No additional information is available.
 
Additional Manufacturer Narrative
The device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Pressure test and clear passage under water was performed and the results were satisfactory.Priming was performed at the set with a bag of sterile water and no issues were observed.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
CLEARLINK SOLUTION SET
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
MDR Report Key12416157
Report Number1416980-2021-05411
Device Sequence Number3576634
Product Code FPA
UDI-Device Identifier00085412046433
UDI-Public(01)00085412046433
Combination Product (Y/N)Y
Initial Reporter StateIL
Initial Reporter CountryUS
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,health
Initial Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date (Section B) 10/05/2021
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 Number2H8603
Device Lot NumberR21E05102
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/20/2021
Initial Date Received by Manufacturer 08/10/2021
Supplement Date Received by Manufacturer09/28/2021
Initial Report FDA Received Date09/02/2021
Supplement Report FDA Received Date10/05/2021
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured05/06/2021
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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