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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
Device Problem Air/Gas in Device (4062)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/09/2021
Event Type  malfunction  
Manufacturer Narrative
Device manufacturer address 1: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a clearlink system non-dehp solution set filled with air.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.
 
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
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
MDR Report Key12461480
MDR Text Key271080575
Report Number1416980-2021-05623
Device Sequence Number1
Product Code FPA
UDI-Device Identifier00085412074764
UDI-Public(01)00085412074764
Combination Product (y/n)Y
PMA/PMN Number
K952074
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 10/13/2021
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
Device Operator Health Professional
Device Catalogue Number2H8486
Device Lot NumberR20J17034
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/16/2021
Initial Date FDA Received09/13/2021
Supplement Dates Manufacturer Received10/06/2021
Supplement Dates FDA Received10/13/2021
Date Device Manufactured10/19/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
ENTERAL NUTRITION.; ENTERAL NUTRITION
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