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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 Air/Gas in Device (4062)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 08/10/2021
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 a clearlink system non-dehp solution set had air in line.It was stated that the set was primed for use with enteral nutrition.When the nurse inverted the filter to attach the line to the patient's central line, the line began to fill with air from the male luer adapter back toward the filter.There was no patient involvement.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 SOLUTION SET
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
MDR Report Key12452670
Report Number1416980-2021-05569
Device Sequence Number1180014
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 Other
Type of Report Initial,Followup
Report Date (Section B) 10/12/2021
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 NumberR20J17034
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 08/16/2021
Supplement Date Received by Manufacturer10/06/2021
Initial Report FDA Received Date09/10/2021
Supplement Report FDA Received Date10/12/2021
Date Device Manufactured10/19/2020
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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