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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTERLINK SOLUTION ADMINISTRATION SETS; SET, ADMINISTRATION, INTRAVASCULAR
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INTERLINK SOLUTION ADMINISTRATION SETS; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 2C6671
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/18/2021
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 an interlink system extension set leaked from unspecified location.The event occurred during an unknown process step prior to use.There was no patient involvement.No additional information is available.
 
Additional Manufacturer Narrative
Additional information was added to h4 and h6.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
INTERLINK SOLUTION ADMINISTRATION SETS
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
MDR Report Key12174897
Report Number1416980-2021-04335
Device Sequence Number16377858
Product Code FPA
UDI-Device Identifier00085412003993
UDI-Public(01)00085412003993
Combination Product (Y/N)Y
PMA/510(K) Number
K153158
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 Other
Type of Report Initial,Followup
Report Date (Section B) 08/17/2021
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 Number2C6671
Device Lot NumberR20J12050
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/18/2021
Supplement Date Received by Manufacturer08/12/2021
Initial Report FDA Received Date07/15/2021
Supplement Report FDA Received Date08/17/2021
Date Device Manufactured10/13/2020
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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