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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: Y EXT W/VLV PORTS & 2 SLD CLP; INTRAVASCULAR ADMINISTRATION SET
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Y EXT W/VLV PORTS & 2 SLD CLP; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 20019E
Medical Device Problem Codes Complete Blockage (1094); Restricted Flow rate (1248)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 07/11/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.No product or photo was returned by the customer.The customer complaint that they are not able to prime or flush could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because a lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.A trend for this occlusion issue has been identified for this product line.Capa# (b)(4) has been initiated, and a team has been assembled in order to investigate the issue.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
 
Event or Problem Description
It was reported that 3 y ext w/vlv ports & 2 sld clp tubing sets were blocked/occluded and would not prime or flush.The following information was provided by the initial reporter: "smartsite sku 20019e not priming or flushing.This is the third incident that they are reporting.".
 
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Brand Name
Y EXT W/VLV PORTS & 2 SLD CLP
Common Device Name
INTRAVASCULAR ADMINISTRATION SET
MDR Report Key12294759
Report Number9616066-2021-51742
Device Sequence Number3806873
Product Code FPA
UDI-Device Identifier27613203013813
UDI-Public27613203013813
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K061285
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source other,user facility
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 07/13/2021
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
Operator of Device Other
Device Model Number20019E
Device Catalogue Number20019E
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/12/2021
Initial Report FDA Received Date08/09/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
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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