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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CLEARLINK I.V. ADMINISTRATION SETS WITH CONTROL-A-FLO REGULATOR; SET, ADMINISTRATION, INTRAVASCULAR
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CLEARLINK I.V. ADMINISTRATION SETS WITH CONTROL-A-FLO REGULATOR; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 2C8891
Medical Device Problem Code Backflow (1064)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/25/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event or Problem Description
It was reported that there was backflow while using a clearlink system extension set.It was further reported that the nurse hung the secondary line to the y-site above the clearlink system extension set and the "k-rider" back primed into the primary fluids.This was identified during 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 I.V. ADMINISTRATION SETS WITH CONTROL-A-FLO REGULATOR
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
MDR Report Key12452992
Report Number1416980-2021-05573
Device Sequence Number11057682
Product Code FPA
UDI-Device Identifier00085412046396
UDI-Public(01)00085412046396
Combination Product (Y/N)Y
Initial Reporter StateMO
Initial Reporter CountryUS
PMA/510(K) Number
K121634
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 Nurse
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 Number2C8891
Device Lot NumberDR20I22068
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 08/16/2021
Supplement Date Received by Manufacturer10/07/2021
Initial Report FDA Received Date09/10/2021
Supplement Report FDA Received Date10/12/2021
Date Device Manufactured09/23/2020
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
Concomitant Medical Products
and Therapy/Usage Dates
K-RIDER; UNSPECIFIED FLUIDS; UNSPECIFIED SECONDARY LINE; K-RIDER; UNSPECIFIED FLUIDS; UNSPECIFIED SECONDARY LINE
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